Working for a Living, Part Three: Pretending to be a professional, January 1997 – Summer 2025

One of the highlights of my career in Regulatory Affairs, the FDA approval of the Edwards Lifesciences Model 11000M Mitral Valve Bioprosthesis.  Source:  https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150048S012A.pdf

The aforementioned approval pawed the way for one of Edwards’ most successful mitral valve replacements, the MITRIS RESILIA Bioprosthesis.  Source:  https://www.edwards.com/healthcare-professionals/products-services/surgical-heart/mitris-resilia

For some reason, this whole week I’ve been on an Astrud Gilberto kick, listening over and over to a YouTube of the very best of her hits.  I love her simple style, and the bossa nova beats are soooo soothing, especially when one is writing about one of the most stressful aspects of adult life, working for a living!  Now, for those of you who may have read the first chapter in this saga, as you read the following you may ask yourself “how come the dates were so precise working back in Sweden, but now, many of the dates are “ish” which signifies a certain uncertainty?”  Well, over the years I have “perfected” my resume writing, and with input from quite a few HR professionals, at some point we no longer indicated what month we started working, and in what month we quit.  Instead, the idea today is to just list the year, especially if the employment was short (like my four months I spent working at Dental, Medical Diagnostics, but more on that later).  Also, when I’m writing about things that happened some 25 years ago, my memory is a bit fuzzy!  So here it goes; some 28 years of working for a living as a Professional, trying to find my way as a “Desk Jockey”, navigating the peculiar ways that many of us Professionals have to get used to, like not having many immediate tangible results; instead relying on the number of emails we send in a day to try and figure out if we actually did something useful!  Good work if you can get it!            

Seal Science in Irvine, CA, working as a sales engineer, spring-summer 1997 

In early January 1997, armed with my new diploma from Cal State Long Beach, I started seriously hunting for an engineering job, and I landed a position as a sales engineer (glorified sales guy) at Seal Science in Irvine, making a reasonable salary, but more importantly I now had company health insurance!  Seal Science was a super interesting place; keep in mind that this was my first professional job!  I had never worked in an office before, and this was an entirely new experience, to be cooped up in one place for 8-9 hours per day, with the same people and the same routine, sitting in a cubicle.  How strange that was!  Seal Science made custom seals and custom vacuum cups, and was segmented into two distinct areas; the front office where I and the rest of the office staff sat, and the actual manufacturing facility, which housed all the rubber molding machines, and also the warehouse.  At the time when I started, there were some 35 of us at the Irvine plant, with 5 or so employees at Seal Science’s Pennsylvania sales office.  Most of Seal Science’s business was custom seals, but we also functioned as a sort of retailer for elastomeric products like various rubber sheets and vacuum cups from other manufacturers.  (Mind you, Seal Science is still in business but is now part of Integrated Polymer Solutions (www.sealscience.com)), so if you need a custom seal, this is the place).  Frederick “Rick” Tuliper, the owner/manager was a bit leery of me, being a 41-year old recent college graduate, but hired me anyway (I was his first degreed engineer).  Rick was a super colorful guy, and I ended up learning a whole bunch from Rick, including how to actually function in an office environment (unfortunately, Rick died at the young age of 70 in 2019, probably from bladder cancer, judging from his obituary).  Rick had a very interesting teaching style; no matter what your position, you would start in the molding plant, working the rubber molding machines and other equipment.  So right off the bat you had a good understanding of the business, which really helped when I eventually moved into the office for my “sales engineer” job.  I still remember the distinct smell of un-cured silicone, a slightly sweet and flowery fragrance, which hung over the manufacturing area.  Since the thermoset curing cycle was usually 5-6 minutes, the key was to operate two molding machines at a time.   

A picture of a rubber molding press.  The steel mold halves would be mounted in the heated press.

 

Steel mold for making o-rings.  The uncured rubber would be placed in chunks in the mold cavities, and the press would press the two halves of the mold together, squeezing out the rubber before the heat of the molds and the press would set the rubber.  Ergo the name “thermoset” for an elastomer that relies on heat to cure.  Seal Science molded thousands upon thousands of o-rings, like the ones you see in the picture above.

Two weeks later when I moved into the office, I was incredibly lucky to work alongside Douglas “Doug” Albin, who was the consummate sales guy, and also one of the most incredible and generous people I have ever met.  I learned a ton from Doug, and I’m forever grateful for his guidance.  Doug worked for Seal Science until 2022, when he finally retired.  Doug passed away in 2023 at the age of 83, so he worked until he was well into his 80s!  Doug knew everything about custom suction cups, which are used for pick and place in high volume manufacturing. 

Our job as sales engineers consisted of cold calling potential customers; Rick had a running ad in one of the trade magazines, and if you showed interest, we would call you and ask you if you had any immediate needs, and if you wanted one of our brochures.  The goal was to make at least 100 calls per day, and most days I sent out (via the US Postal Service) 4-5 catalogues. 

Later, I moved into quoting of custom rubber seals and other elastomeric products (i.e. widgets).  The quotes usually consisted of two components; the custom steel mold, and the piece price per rubber widget, depending on the size of the order (steel molds are made with a certain number of cavities, and since each cycle is about 5 minutes, for larger quantities, the piece price would usually be less expensive with a larger, i.e. higher number of cavities, mold).  I had written a little Excel routine, which would give the customer an idea of how many widgets it would take in order to make the piece price go down, even though the higher number of cavities in a mold usually meant a higher initial price for the mold.  We had two fax machines, and we would fax off the completed quotes and hope for an order.  I had also started to take some Autocad classes, so at least I could make some very rudimentary drawings, which came in handy on occasion.  During this time, I got very familiar with all kinds of rubber compounds; Natural Rubber, Butyl Rubber, Nitrile Rubber, Ethylene Propylene Diene Monomer (aka. EPDM), Silicone Rubber, Polyurethane Rubber and Viton, which is used for high temperature and harsh chemical applications.  Whenever somebody asked for quote on a custom seal, the first question was always “what is the application?”  There were four of us that sat in the front office, in open cubicles which we called the bull pen.  This was also the first time I saw somebody leave our office crying in the middle of the day (thankfully to this date, there has only been one other time, but more on that below), after an exceptionally challenging morning at the office (this person eventually calmed down and returned to the office in the afternoon).  I liked working at Seal Science, I learned a whole bunch, and the camaraderie was great. Nevertheless, by the fall of 1997, I had found a better paying job, working for Horizon Medical, but that story will unfold below.

Home Depot, Laguna Hills, CA, part-time sales associate, September(ish) 1997 through May 2001.     

(My) The Home Depot, 24332 El Toro Road, Laguna Hills, CA.

 By the summer of 1997, Kathy and I had decided to try for a third child, and in order for us to save a bit of money so that Kathy could stay home when this yet-to-be-conceived child came, in the fall I started working at Home Depot in Laguna Hills, CA, in addition to my day job at Seal Science.  I had applied at Home Base (which was in competition with Home Depot), and also at Bed, Bath and Beyond (a home goods store), but I finally landed the job at Home Depot, working nights and weekends.  In addition to the applications, all three stores used some sort of written personality trait questionnaire; I remember Home Depot’s questionnaire was over 90 questions, many of them questions like “have you ever shoplifted?”, “when you shoplift, do you do it alone or with a friend?” and my favorite “have you ever had a fist fight with any of your former employers?”.  This was designed to weed out the most egregious bad apples, but some of them still got through!  Well, I must have passed the test and I started at the newly built Laguna Hills Home Depot sometime in September of 1997, just about a month before the store was to open.  To make a long (and mostly boring) story short, we had initially planned for me to stay at Home Depot for 4 to 6 months, but I ended up staying for about 3.5 years, usually working 25 hours plus a week, in addition to my day job at Horizon Medical, Dental, Medical Diagnostics and Newport Corporation (the story will unfold below).  This was a good time to be at Home Depot, the company was growing rapidly, and the stock was doing very well (I think it split twice while I was there), and I bought as much stock as I could under the employee stock purchase plan.  With me working at Home Depot, we were able to pay off our credit card debt, and subsequently saving up enough money for a down payment on a house, which we bought in 2000, when the 1990 bankruptcy had been cleared off our records.  Also, I was a (relatively) young guy, and the hours didn’t bother me, especially since I was working for a higher purpose. 

Working part-time at Home Depot was an interesting experience; I would drive from my engineering job dressed in my slacks, wing-tipped shoes and starched dress shirts (and often a tie) and change into my Home Depot grubby clothes in the bathroom.  In the fall and winter I would usually be in building materials or hardware (which I truly enjoyed, since I love tools), but in the summer I would usually be moved to outside garden, working stacking bags of soil, moving plants, stocking the shelves and helping customers.  I also got my forklift license, and I must say that driving a forklift is great work, I just wish it paid better!  Also by Christmas, I would be out in the Christmas tree lot, usually with another bunch of us older guys (you would think that the younger guys would like that job, but they liked to hide inside the store where the work was easier, tsk, tsk…  Whenever I would see one of the young guys walking around with their hands in the orange Home Depot aprons, I would yell at them “get your hands out of your pockets”, since there was always a bunch of stuff to do, you just had to look).  There were quite a few of us guys who had day jobs, and the camaraderie at Home Depot was a lot of fun.  This was a time when at each after-closing meeting, where all of us employees in the store would meet at the front of the store, we would shout the Home Depot chant “give me an H, give me an O, give me an M, etc.”.  Then we would go over the day’s sales numbers, and talk about any issues.  I have never regretted working for Home Depot, and I still have a fondness for “my” store in Laguna Hills, even though I now shop at Lowe’s in San Clemente since it is much closer.  Also, after Matthew was born in December of 1998, Kathy went to work at Home Depot in the spring of 1999 as a part-time sale associate, working at the Mission Viejo, CA store.  She ended up working for Home Depot for some five and a half years, before finally quitting sometime in 2005.  Nevertheless, these were trying times; I would work Monday night, Wednesday night, and Saturday and Sunday.  Kathy would work Tuesday night and Thursday night, so we would have Friday night together as a family, and squeeze in as much family time as we could during these precious Fridays.  But we persevered, and as I mentioned above, by 2000 we were able to buy a house, which signified the road to recovery after the Little Professor debacle in 1990. 

Horizon Medical, Santa Ana, CA, working as a Project Engineer, fall 1997 through early 2000.

In order to make a few more bucks, in the summer of 1997, I started to look for another job, and I answered a “blind ad” (an advertisement that didn’t really give any information about the job) in The Orange County Register, wherein this Horizon Medical was looking for an engineering type, but again, there wasn’t much information.  Horizon Medical was initially located at the intersection of Grand Avenue and Edinger Avenue in Santa Ana, CA, but we later moved to a custom-built facility at 1900 Carnegie Avenue in Santa Ana, on the other side of the 55 freeway.  Horizon Medical specialized in assembly and packaging of medical devices, and they would also manage the shipping of the products to get sterilized, kinda like a one-stop shop for contract medical device manufacturing.  At the time Horizon Medical was probably around 75 people, including the assembly personnel in the cleanrooms, so we were a pretty close-knit group.   Well, I interviewed and got the job, working as a Project Engineer, which meant that I worked as the interface between the customer and Horizon Medical, ensuring that the customer’s medical device was integrated into Horizon’s systems.  This was my start in the Medical Device business, and as of this writing (summer 2025) I’m still at it!  We would assemble and package pretty much anything medical device related, from simple tubing sets for liposuction all the way to sophisticated asthma medication delivery systems, complete with integrated electronics.  I would spend at least half the day out in the clean rooms, and the rest of the day up in the office.  I also spent a lot of time with our customers and our vendors, and since I like people, I was pretty good at it.  This is where I learned my method of working as a professional; if your boss asks you to do something, do something, anything!  If I was asked to work on a validation project (even if I didn’t have the slightest clue what that meant), I would look for some previous work, and copy what I could, and then present it for editing.  I learned my part of the business pretty quick, and I also got to know a couple of people that I later worked with at Edwards Lifesciences.  The Medical Device industry in south Orange County is very closely connected, and since we all talk, the key is to always be on your best behavior, keep your nose clean, and don’t burn any bridges!  You never know who you will be working with, who you will be working for, or who will work for you, it just might be somebody you already know from another medical device business!  In the approximately two and a half years I worked there, I learned a ton of stuff about the medical device industry, and as I mentioned above, I got to know Chris and Cristina, both of whom I still see at Edwards Lifesciences, when I have occasion to visit the Edwards’ campus.  I worked with clients like ALZA corporation (which was a pharmaceutical company) where I worked on their leuprolide drug delivery system; BIEX (who was developing a test to identify high-risk pregnancies), where I worked on their test system; Advanced Sterilization Products, where I worked on their sterility assurance test system (and where I met Cristina); Kinetic Concepts Inc. (KCI) where I worked on their vacuum-assisted wound care system; Johnson and Johnson (or J and J as we know them), working on a safe blood test needle project, and a whole host of other clients and their projects and products.  I also learned a bunch about ultrasonic welding, and eventually became Horizon Medical’s ultrasonic welding subject matter expert (or SME as we like to call them), eventually validating four (or five) brand new Branson ultrasonic welders for KCI.  A great place to work for somebody that is pretty much brand new in the Medical Device industry, and again, I learned soooo much in a relatively short time.  Also, when we moved from the intersection of Grand and Edinger to our custom-built facility over on Carnegie, even more learning opportunities presented themselves, especially when it came to equipment and process validations, something that I’ve carried with me ever since.               

Dental, Medical Diagnostics, Irvine, CA, working as a quality engineer and quality manager, spring 2000 (4 months).

So, if Horizon Medical was such a great place to work, and the learning opportunities seemed to be endless, why go anyplace else?  Well, in the end, no matter how interesting the job, we all work for money, and during my two and a half years at Horizon, my raises had been pretty much nil.  So, it was time to move on!  Keep in mind that all during this time I still worked part-time at Home Depot, and it just so happened that two of my buddies at Home Depot worked for a small dental medical device company in Irvine, Dental, Medical Diagnostics, and they seemed to like the company well enough.  Dental, Medical Diagnostics built and sold early generation dental filling curing systems, consisting of an ultraviolet light source, a light tube, and various glass light tips. Well, I interviewed and got a job as a Quality Manager, and a reasonable bump in salary, and my own office!  I also performed the duties of a Quality Engineer, working on customer complaints and such.  The company was headquartered in Woodland Hills, but the manufacturing and assembly facility was down in Irvine, where I was stationed.  So, why only four months at Dental, Medical Diagnostics?  Long story short; the business was rapidly going under, and not long after I left, Dental, Medical Diagnostics closed their doors.  Not long before I started in the spring of 2000, Dental, Medical Diagnostics had gone public, and initially the shares sold for $10.00 a share; however, by the time I started, the shares were selling for pennies.  There were other signs; outside of my office, we had a burn-in station, where the electronics were plugged in for a 24-hour test run.  During the test run, the equipment would constantly beep, which was really annoying.  When I started, the beeping would almost be deafening, but as the weeks and months went on, we had less and less equipment hooked up for burn-in, and the beeping almost stopped entirely. Also, our poor purchasing agent was using the owner’s credit cards to buy components, juggling the maxed-out credit cards.  Fortunately for me, after four months at Dental, Medical Diagnostics, I left to start working at Newport Corporation, which was another adventure entirely. 

Unfortunately, Dental, Medical Diagnostics filed for bankruptcy on July 24, 2001, closed its doors, and rumor had it that the owner fled to Canada to avoid creditors, but I have no evidence to back that up.  Ed, the vice president of engineering and research and development at Dental, Medical Diagnostics, took the furniture and his three engineers from the Irvine office, and set up his own contract engineering firm.  A few years later, by chance I met Ed at his office, and I recognized both the furniture and his engineers.  They did all kinds of contract engineering work, including the design of sophisticated sex toys.  As Ed said, “somebody gotta do it!”.  In the end, a dollar is always green, no matter where it comes from…               

Newport Corporation, Irvine, CA, working as a Senior Project Manager, early summer 2000 through September 2001.

Newport Corporation; 1791 Deere Avenue, Irvine, CA.  In February 2016, MKS Instruments out of Massachusetts bought Newport Corporation.

 As I started to realize that Dental, Medical Diagnostics was about to fold, I started to look for work elsewhere, and I started to send out my resume in earnest.  In the early summer of 2000 I lucked out, and got a job as a project manager at Newport Corporation in Irvine.  Newport Corporation (or NEWP as it was known on Wall Street) had been a Wall Street sleeper for ten years; during the time from 1990 through 1999, the stock had consistently hovered around $10.00 per share, sometimes reaching $11.00, then dipping down to $9.00, then back up to $10.00, nothing special for sure.  However in 2000, Newport Corporation was experiencing a great growth spurt driven by its close ties to the fiber-optics industry, and according to Google “In 2000 Newport's performance gained the attention of Wall Street, which drove up the price of its stock at a breathtaking rate. Over the first six months of the year, shares rose 581 percent to more than $107, making it the sixth best performing stock on the NASDAQ in the first half of 2000. Newport's ascent was remarkable because so many other tech stocks stumbled during the spring. By late September the price hit a high watermark of $189 (after a three-for-one split, no less), a 1,000 percent increase for the year. Before 2000 closed, however, Newport arranged to use its stock to acquire Kensington Laboratories, maker of robotic automation systems, serving the semiconductor industry that Newport would adapt to fiber-optic component assembly and automation. The deal closed in February 2001.  The fiber-optics market tailed off dramatically in 2001 as the telecommunications sector entered a severe downturn. With customers postponing investments, Newport was adversely impacted, forcing a number of cost-cutting measures, including a major reduction in the workforce. Fortunately for Newport it could still fall back on its semiconductor and metrology businesses, each enjoying strong success in 2001 while the fiber-optic business stumbled. Nevertheless, the loss of fiber-optic sales was a hard blow, leading to two years of further job cuts and more belt-tightening efforts, such as consolidating six of its 12 plants. Newport lost $6.3 million in 2001 and more than $100 million a year later. Not surprisingly the price of Newport stock plummeted, as far as $10 before rebounding.  (source:  https://www.encyclopedia.com/books/politics-and-business-magazines/newport-corporation)”.  I can corroborate all of the aforementioned, because I was there, and I saw it firsthand.  Having been hired in early summer of 2000, I was first stationed at Newport’s Irvine headquarters, where pretty much everybody was looking at the New York Stock Exchange ticker for NEWP (a lot of people got quite rich during those crazy days) as the stock seemed to be on a forever upswing.  I remember one of the long-time engineers suddenly showed up in a new Ferrari, good for him!  Not long thereafter (late summer 2000) I was moved to the Newport Corporation’s Garden Grove optics manufacturing plant, where I was primarily focused on quoting new optics (my quoting skills that I had learned at Seal Science came in handy).  First I was sitting in a room with four other optics engineers, but I eventually asked to move closer to the manufacturing operations.  Since I had no previous experience with custom optics, being close to the actual action really helped with trying to understand what customers were looking for.  With the share price being stratospheric, the Newport Corporation Christmas party in 2000 was epic; no expense was spared.  Also, since at the time it was believed that all copper communications were going to be replaced by fiber-optics, many investors believed that there was no down-side to the fiber-optics craze.  However, as economists Carmen Reinhart and Kenneth Rogoff pointed out in their bestselling book “This time is Different; eight centuries of financial folly”, what goes up must come down…  And so it did; as mentioned above, after NEWP’s stock reached $189 in September of 2000, the roller coaster had finally reached it’s zenith, and the ride downhill was both fast and scary.  In the beginning of 2001, with the stock starting it’s decent, rumors of layoffs started, and sometime in spring-early summer of 2001, about 10% of Newport Corporation’s workforce was laid off.  This was an interesting time; after the first wave of layoffs, the workforce quite quickly crystallized into two distinct camps; the first and scared camp, where some people started working 10 hour days, six days a week to show that their efforts would be irreplaceable, and that their work was needed.  On the other hand, the other camp started taking two-hour lunches, coming in late and leaving early; the thinking being that if they were going to be laid off anyway, why bother?  I probably fit in somewhere in between, doing my job the best as I could.  Also, after the first wave of layoffs we were told that there would be no more, and we felt relatively safe.  However, in late September of 2001 (not long after the September 11, 2001 terrorist attacks on the World Trade Center and elsewhere), and with the NEWP stock down at $13.00 (ouch), on a Tuesday morning, around 7:15 AM, my boss showed up at my desk with the HR lady, saying “we gotta talk”.  And so it was that sometime in late September 2001, I was laid off from Newport Corporation, the first time (and the only time so far) that I’ve been laid off.  I remember coming home at about 1:00PM in the afternoon with a box of my stuff; Kathy was ironing in the hallway, and since she knew where Newport was heading, there was not much to say… 

So what happened?  As Robert G. Deuster, the 2001 president and CEO of Newport Corporation said “In the two months since our last update, many of our customers in the fiber optic communications and semiconductor equipment markets in the U.S. and Europe have implemented additional restructuring programs and suspended a significant portion of their capital spending plans. We have continued to experience cancellations and push-outs of existing orders and a deterioration of new order flow in our fiber optic communications business as our customers deal with excess manufacturing capacity and severely reduced demand from their customers for components. Additionally, the current weakness in our semiconductor market has been exacerbated by a recent string of order push-outs by several large semiconductor equipment customers relating to products for optical and robotic applications, due to apparent delays in 300 millimeter production tool deployments.”  (Source:  https://www.globenewswire.com/news-release/2001/09/10/282526/750/en/Newport-Corporation-Revises-Outlook-for-Second-Half-of-2001-Cites-Further-Market-Weakness-and-Announces-Additional-Cost-Reduction-Plans.html).  Also, Newport Corporation was fourth-tier manufacturer and with the general downturn in 2001, things did not go well; Newport would make the optics (4) that went into the machines (3) that were used for making semiconductors (2), that were ultimately sold to the likes of Dell, IBM and Hewlett-Packard (1).  So, any loss of sales by the likes of Dell and IBM would reverberate all the way down to the likes of Newport. 

Fall 2001 through Spring 2004:  Back at school, working on and earning my Master’s Degree in Business Administration (MBA) at California State University, Fullerton.

California State University, Fullerton (CSUF); 800 N. State College Blvd, Fullerton CA.

I had first attempted to earn my MBA at Fullerton starting in the fall spring of 1998 while working at Horizon Medical; however, working two jobs (Horizon and Home Depot) was just too much, and about six weeks into the spring semester I dropped out.  However, sometime in the fall of 1999, I wanted to go back to CSUF, and sometime in 2000, I reapplied.  I was subsequently accepted, and again I started working on my MBA in the fall semester of 2001.  Since I was an Engineering graduate from Cal State Long Beach with no business classes, I had to take a boatload of classes: 

My study plan for my MBA at CSUF.  I eventually ended up taking 17 classes over three years including summer classes, all of them night classes, graduating in the spring of 2004.

 The initial plan was not bad; I had quit Home Depot in May of 2001 so I had the time, and Newport Corporation had an education reimbursement program in place, so the idea was that I would essentially go back to school for free!  Even when I got laid off from Newport in September 2001, they still honored their educational reimbursement, so at least I got one semester paid for!  In order to finish in three years, I took 2-3 classes per semester, including summer classes.  Fortunately, Cal State Fullerton was relatively inexpensive, and even though I had to pay out of my own pocket, after three years I had “only” spent some $15,000 on my MBA, which, compared with most MBA programs, was a bargain!  The MBA program at CSUF was academically solid, and when I graduated, I was truly proud of my accomplishment.  However, since CSUF accepted students with fresh bachelor’s degrees, the student body was not as experienced as compared with many of the more expensive programs, which oftentimes requires at least five years working experience to be admitted.  Ergo, from this fact I coined the saying “if you are going to spend $60,000 on your MBA at the likes of University of California just for the network, then you darn well better network!”

Since my business studies at Cal State Fullerton, I’ve always have had a great affinity for the school.  In addition to my MBA, my wife Kathy, our kids Chelsea, Michael and Matthew all graduated from CSUF, in addition to Chelsea’s husband Patrick who is also a CSUF Alumni.  Later, in the fall of 2015, I returned to CSUF as an adjunct professor, teaching eight semesters before quitting in the spring of 2019, but that story will unfold below.  Go Titans! 

The Cal State Fullerton Titans, which represent CSUF athletic teams.

 Micro Therapeutics, Inc.  Manufacturing Engineer, February 2002 through July 2004.

A Micro Therapeutics, Inc. brochure for Onyx, a liquid embolic system, approved for and used to treat arteriovenous malformations (AVMs).  Onyx is a viscous liquid made up from ethylene vinyl-alcohol copolymer (EVOH), dimethyl-sulfoxide (DMSO) which allows the EVOH to stay in a semi-liquid state before injection, and micronized tantalum powder, which allows for radiographic visualization.  As the Onyx is injected into the vasculature, the DMSO is carried away by the blood stream, leaving behind the now solid chunk of EVOH and tantalum.

After being laid off in September of 2001, I took over the role of stay-at-home parent, while Kathy went to work both night and day, working as a substitute teacher during the day in the Irvine and Tustin school districts, and also working at Home Depot as a sales associate at night and on the weekends.  I would take the kids to school in the morning, then work on various home projects during the day, and then pick up the kids in the afternoon, in addition to cooking, cleaning and doing the laundry.  Let me tell you, this is no easy job!  Since Kathy was working two jobs, I would try and make sure that all her needs were met, to the best of my ability.  I was also going to Cal State Fullerton, working on my MBA, so that kept me reasonably busy.  I was also looking for work like crazy, and back then I think we used the Monster Board for open positions. 

Sometime in October of 2001, I got an interview with a company in Irvine, Micro Therapeutics, Inc (or MTI as we knew it back then), but I didn’t get the job.  However, they called me back in the beginning of 2002 (or I called them, I don’t exactly remember), and Micro Therapeutics, Inc., located at no. 8 Goodyear in Irvine, finally hired me, and if my memory serves me, I started working at MTI in the middle of February, 2002, working as a manufacturing engineer.  Micro Therapeutics was (and still is, under its current Medtronic ownership), specializing in neurovascular and peripheral treatments, developing and manufacturing embolic coils, liquid embolics (Onyx, which I supported), thrombectomy catheters and occlusion ballons.  MTIs products are designed to treat brain aneurysms, arteriovenous malformations (AVMs) and peripheral vascular devices.  When I started in early 2002, MTI employed in total some 125 people, including about 80 assemblers and 45 office staff.  We were a pretty tight knit group, and we all knew each other, and as a manufacturing engineer I interacted with all groups; R&D, quality, regulatory and of course operations.  At the time, even though MTI had been in existence for some 10 years (give or take a few), it was still operating as a start-up company, and unfortunately was still burning through money like a start-up.  Nevertheless, my first year-and-a-half at MTI was great; I had a reasonably well-paying job (important when you have three kids and a mortgage), I really liked the people I worked with, and I got to work on some really cool manufacturing equipment, and I did some very in-depth equipment and process validations.  Also, my old friend CF from Cal State Long Beach started working at MTI, probably late 2002 - early 2003, as a quality engineer.  If my memory serves me, she quit MTI  before me, probably in early spring 2004.  (CF and I have stayed in touch via LinkedIn ever since, checking in periodically, and she has stayed in the medical device field, just like me.  To my great surprise, in July of 2025, we had a chance meeting when I got my prostate MRI).  I primarily supported the Onyx liquid embolic system and also catheter manufacturing, and as always learned a ton!  MTI had just bought a new liquid injection molding machine to mold catheter hubs, which became known as “Peter’s machine”, since I did all the validation work, wrote all the set-up instructions, and did a ton of trouble shooting.  I got to know more about mold flows and knit-lines than I ever needed to know, but it was a great time (unfortunately, after about a year-and-a-half, that machine was taken out of service, since we never had the number of device orders that would support a high capacity molding machine, and I think it was eventually sold for scrap)!  I also performed a lot of returned product evaluations, investigating the returned devices, and document my findings and conclusions, which became part of the complaint files.

By 2003, MTI had instituted a bunch of lean manufacturing improvements, such as the two-bin system for components and sub-assemblies, and highly simplified manufacturing procedures.  We also had a light system that was attached to each manufacturing line,  consisting of a three-light indicator; green meant that the line was running without any problems; yellow meant that they were waiting for components, and red meant that the line was down for some other reason, like an equipment failure.  First thing we did in the morning when we came in was to check the lights; if the light was green, we would start our day like normal, but if the light was red, we rushed in to the clean room to figure out what was going on to get the line up and running ASAP.  Not a bad system!        

However, MTI continued to lose money; if I remember correctly, in 2002 MTI lost some $24 million, on sales of $12 million (so, for every dollar MTI made in revenue, they spend two).  In the middle(ish) of 2003, MTI started to look for new capital to stay afloat, and ev3 came into our lives.  Endovascular 3 (or ev3), was focused on endovascular diseases, and MTI fit nicely into their portfolio.  (ev3 was later bought by Covidien, and later still Covidien was bought by Medtronic).  Nevertheless, with ev3 breathing down our necks, the culture at MTI changed rapidly, and people started to get fired, and unceremoniously led out of the building.  The new MTI CEO Tom Wilder (which I believe was put in place by ev3) obviously wanted to shake things up, especially given the poor results from 2003, when MTI lost some $48 million, on sales of about $24 million (still, for every dollar MTI made in revenue, they spent two…). 

And now something for you medical device nerds:  This was also the first time I experienced a crazy quality manager instituting a situation wherein you could close out a Non-Conformance Report (or NCR, which should usually be closed out within one to two weeks), as long as you opened a Corrective and Preventative Action (CAPA, which “normally” stays open for months).  This meant that if you had a work order that was held up by an NCR, you could close the NCR with a CAPA number, and ship out the stuff, as long as the NCR had been corrected, and no immediate investigation was needed.  The outcome was as expected; the number of CAPAs exploded, and we just didn’t have the manpower to close out the CAPAs, which of course would look really bad in an audit.  When some years later when the Vice President of Quality at Edwards Lifesciences instituted a similar policy, I was aghast, and again the number of CAPAs skyrocketed.  I told you so!!!!      

So, in this rapidly changing atmosphere, I found myself for the second time witnessing an employee leaving the building crying; one of our operations planners had apparently been yelled at, and she stormed out crying (I don’t think she returned).  It even got so bad that in the spring of 2004, I myself was threatened with a firing, with my boss’s boss telling me “if you don’t shape up, you’ll be out of here in two weeks”.  That’s after having received a great performance review the year before, what’s happening here?  That Saturday I went into the office and cleaned out my cubicle of any personal belongings, save for one family picture.  My thinking was that if I was going to get fired, I would just take my one photo out of my cubicle, stick it in my pocket, and walk out with my dignity intact, no fuss, no muss.  That weekend alone I probably sent out 50 resumes, to anybody that had an opening that would even remotely match my skill set.  Also, by 2003 MTI had installed a new key system, which required a key fob to get into the building, which was initially met with some reservations (no trust?).  However, the ev3 folks came and went as they wished, so we know who was running the show in the background.  Weird bad times, I’ll tell ya!

Anyway, I was in the last semester of my MBA program at Cal State Fullerton, and I had already made up my mind that after I graduated in May of 2004, I would look for another job (one of my professors at CSUF had told us that an MBA was perishable; if you didn’t get a new job within some six months, people would start asking why you pursued an MBA in the first place…).  Again, with the specter of being fired, I doubled up on my job search, and as luck would have it, and with my fresh MBA in hand, by the end of July, 2004 I had found another job, this time at a true start-up, AcuFocus in Irvine, but more on that story below.  When I left MTI in July, this was the first and only (so far) time I didn’t give a two-week notice; instead, I got the job offer from AcuFocus on a Monday, on Tuesday I told my boss and HR that by that same Friday I would be gone, out of their hair.  My young boss told me “I don’t blame you…”.  Too bad; for most of two years I had truly enjoyed working for MTI, learned a bunch, and hopefully contributed enough to pay for my salary, but it was high time to leave that toxic environment.                        

But maybe there is some poetic justice after all; in 2018, ev3 pleaded guilty to charges related to the Onyx Liquid Embolic System, and paid $17.9 million in fines, per the Department of Justice.  Onyx (which I supported as a manufacturing engineer in 2002 – 2004), was approved as a liquid embolization device which is surgically injected into blood vessels in the brain to block the flow of blood to arteriovenous malformations (AVMs) in the brain, and was only approved by the FDA for use in the brain (I actually worked on that FDA submission, writing the manufacturing information, which actually earned me a $500 bonus).  Per our friend Google, “Despite the FDA’s limited approval of Onyx, from 2005 to 2009, ev3 sales representatives encouraged surgeons to use Onyx in large quantities for unproven and potentially dangerous surgical uses outside the brain.  The company’s sales force continued to tout unapproved and potentially dangerous uses of Onyx even after FDA officials told ev3 executives that they had specific safety concerns regarding uses of Onyx outside the brain at a 2008 meeting.  FDA officials told ev3 executives that a study would be required to gain approval for uses of Onyx outside the brain and to ensure that the benefits of the device outweighed the risks. 

Rather than conduct a study to ensure the safety and effectiveness of Onyx for uses outside the brain, ev3’s sales representatives sometimes attended surgical procedures and provided explicit instructions to surgeons regarding how to use Onyx for unapproved surgical procedures outside the brain, including in quantities far larger than what would be used in the brain.  According to the criminal information, ev3’s management also set-up a system of sales quotas and bonuses that incentivized sales representatives to sell Onyx for unapproved uses and trained the sales force how to instruct physicians on unapproved uses of the device.”  (Source:  https://www.justice.gov/archives/opa/pr/medical-device-maker-ev3-plead-guilty-and-pay-179-million-distributing-adulterated-device). 

Further, ““ev3 disregarded laws designed to protect patient safety,” said United States Attorney Andrew E. Lelling for the District of Massachusetts. “The U.S. Attorney’s Office is committed to protecting patients and the integrity of federal health care programs, and we will continue to use our criminal authority to ensure that medical device manufacturers play by the rules that protect the public and ensure quality of care.”

“Unnecessarily putting patients at risk to increase profits, as the government alleged in this case, will not be tolerated,” said Christian J. Schrank, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.  “We will continue to work with our federal partners and hold accountable companies that use deceptive practices to increase their bottom line.””  So, there appears to be some truth to the old saying that “a fish rots from the head down…”.  Crazy… 

AcuFocus, 18 Technology Drive, Irvine, CA:  Senior Manufacturing Engineer, August 2004 through mid-January 2007.   

The AcuFocus ACL 7000 (or Kamra as it was later called) corneal implant, designed to correct presbyopia.  The ACL 7000 is a 3.8 mm diameter micron-thin disk, with a 1.6 mm circular opening in the middle.  The design is based on the principle of small-aperture optics; the implant is placed in a corneal pocket (Lasic pocket) and positioned over the central zone of the cornea.  The exterior opaque ring blocks the un-focused peripheral light rays, while letting in the focused central rays through the opening, which increases the depth of focus and improves near vision.  Source:  https://www.aao.org/eyenet/article/kamra-corneal-inlay-in-clinic and also my own experience; after all, I worked for AcuFocus for over two years.

 AcuFocus was the quintessential medical device start-up; I was employee number nine (9) when I started in August of 2004.  I had initially interviewed up in Thousand Oaks, some 100 miles from our house in Irvine, but I knew that the company was going to move down to Irvine, so this was great.  When I interviewed, Ed the CEO told me that “our current burn-rate (the rate at which a start-up burns through investment capital) is $800,000 per month, and I have $5 million in the bank, so if we don’t get any more financing, in six months we will be closing the doors.  You still want the job?”  I couldn’t wait to get out of Micro Therapeutics, so I enthusiastically said “You Bet!”  As fate would have it, I stayed with AcuFocus for almost two-and-a-half years, and I was always treated well (although sometimes with a bit of indifference, which is just fine).  I think I spent the first week up in Thousand Oaks, but by the second week we had moved down to east Irvine, and I had a short, nice commute, a bit better pay than I had received at Micro Therapeutics, and life was good!  Now, when I talk to my younger peers in the medical device industry, I usually tell them that doing a stint at a start-up is a really, really good experience, especially if you can do it early in your career, because the learning experiences that can be had at a start-up are pretty much endless, which is reflected in the number of hats that you need to wear in a start-up.  At AcuFocus, even though I was ostensibly hired as a manufacturing engineer, I worked in Research and Development, Operations (since we didn’t do any of our own manufacturing; everything was outsourced), Quality (doing pretty much everything a Quality Engineer would do, including vendor audits), developing (along with my good friend Randall “Randy” May) and implementing the AcuFocus quality system, developing the drawing package, and also the full manufacturing documentation.  It was also while working for AcuFocus that I met Randy May, who became a great mentor and also a good friend, and we spent a lot of time doing vendor audits together.                                

Well, as AcuFocus was running out of money in the fall of 2004, the CEO also got very sick with esophageal cancer, and spent a good month in the hospital recovering from surgery.  He came back in early 2005, looking like the grim reaper.  Nevertheless, as sick as he was, he went on a roadshow to raise money, and after some six weeks on the road, he came back with $26 million (that’s right, twenty-six) in his pocket.  So, with a burn-rate that was now reaching a million a month (we had hired more people, and also moved into a somewhat larger space, also in east Irvine), at least we had some two more years to do our thing!  Our CEO was the consummate sales professional, and his ability to raise money was extraordinary.    

I was busy qualifying a new material for the corneal implant, and also working as the main interface between our manufacturing, sterilization and packaging sites (we still did not do any of our own manufacturing, instead relying on contract manufacturers).  I also worked on the packaging design; since the implant was impregnated with micronized carbon, the outgassing after Ethylene Oxide sterilization, and with the help of Royal Paper Box in Montebello, CA, we came up with a custom system of boxes, that resembled Swizz cheese, in order to allow for airflow.  AcuFocus was doing clinical trials in Turkey, and with those clinical results, we got an FDA Investigational Device Exemption, which allowed us to start a limited clinical trial in the US. 

Since the AcuFocus quality system was completely paper based, we bought a $1,500 fireproof file cabinet, cased in brick (the thing weighed 700 lbs, and had to be placed using a pallet jack.  Even so, as we started to reach some 500 documents, I hired some temporary help to scan all the documents into electronic files, so that it would be readily available for all of us to use.  I also did a fair amount of travel; we had vendors in the Chicago area, in New Hampshire, but primarily in Goleta, CA, and whenever I visited Goleta, I usually ended up staying in the lovely town of Santa Barbara, CA. 

As I mentioned above, working in a startup means that one can learn a whole bunch of stuff, and wear however many hats that one’s head can carry (and having a pretty big head like mine, I carried quite a few, ha, ha).  Since a startup exists to be sold to a bigger entity,   the “product” that a medical device startup has to offer are clinical results, and our results were satisfactory, so much in fact that eventually Bauch and Lomb acquired AcuFocus in 2023; however, that was much later, and I had already left years before.  As I read my resume, at AcuFocus I “managed the sterility validation (EO) and shelf-life study, and all subsequent equipment qualifications and process validations.  [I was] responsible for the manufacturing cycle from raw material procurement, vendor management, purchase orders and final release.  [I] worked closely with quality systems consulting to secure ISO 13485 certification and CE Mark.  As a member of the management team, took part in all internal and external audits and inspections (Notified Body and California State) and vendor audits.”  That’s a whole bunch of stuff, and if you work for a larger company, you will probably never touch so many aspects of a business.    

Nevertheless, even though my work at AcuFocus was both interesting and rewarding (and the autonomy was great), since starting my career in medical devices in 1997 working for Horizon Medical, I had never worked for a “prestige” company (a prestige company is usually a big company, with at least a billion dollars in yearly sales; companies like Johnsson and Johnsson, Medtronic and Becton-Dickinsson comes to mind), and I believed that it was time to add that “prestige” company to my resume.  So, as luck would have it, in the fall of 2006 I was offered a Quality Engineer position at Edwards Lifesciences in Irvine (who was and still is a highly respected medical device company, doing sales of about a billion dollars in 2006), CA, and in the middle of January, 2007, I left AcuFocus (and I did give them the customary two-week notice, mind you).  Even so, I have never regretted my time at AcuFocus, and I also made some good friends in Randy May (whom I also did some consultancy work for), and Randall Danta, who started as a design engineer, and eventually became the director of engineering at AcuFocus.  In 2005, Randall and I started a little band, “BandAid” since one of our members was Dr. Robert Amster, playing bass.  We rounded out the band with Dr. Michael Rugg on guitar, who was a lecturer at the University of California, Irvine (UCI), and we did a few gigs here and there; super fun!  (By the way, you can read more about all my musical interests in some of my other blog posts).

Edwards Lifesciences, Irvine, CA:  Staff Quality Engineer – Compliance specialist, January 2007 through mid-2011.

Edwards Lifesciences, one Edwards way, Irvine, CA.

I had my eye on Edwards Lifesciences for a long time; I would send them a fresh resume every six months or so, and I had an in-person interview in 2002 (which fell through), a phone interview in 2004, and another in-person interview in the summer of 2006, to no avail.  Nevertheless, I persevered, and I had yet another in-person interview in the fall of 2006, and this time I was finally offered a position as a Staff Quality Engineer, starting in mid-January of 2007 (all the time I had spent with Randy May at AcuFocus really helped, since he was the consummate medical device quality system specialist, and some of it rubbed off).  I was initially working on CAPAs, but about three months into my job, I was given the title of “Technical Supervisor”, a title given to some of us engineers that were also expected to supervise a manufacturing crew (or a crew of quality inspectors in my case), when we weren’t working on our engineering stuff!  (It never worked out as expected; the supervisory role took all of our time).  So, all of a sudden, I had 22 direct reports, and I was responsible for training, reviews, hiring, discipline and promotions.  During my time as Technical Supervisor, I got six of my inspectors promotions and raises; to this day when I meet some of my old staff they usually say “when are you coming back?”.  Supervising is as much an art as it is a science; I quickly learned that the 80/20 rule applied; 20 percent of your direct reports would account for 80 percent of your troubles!  However, sometime in 2009, I gave up the supervisory role, and focused on my job as a Quality Engineer, supporting manufacturing, working on Non-Conformance Reports (NCRs), CAPAs and day-to-day problems and issues.

Also in the fall of 2007, since Edwards had a pretty generous educational reimbursement policy in place, I started working on my Masters Degree in Quality Assurance, a program out of Cal State University Dominquez Hills, CA. 

California State University, Dominguez Hills, 1000 E Victoria Street, Carson, CA.

 This was a fully on-line program, which of course meant that I didn’t have to drive to a university; instead I could study at my own pace.  Now, my take on on-line education is the following; it takes a lot of discipline when you don’t have a physical peer-group, so if you are contemplating an on-line program, make sure you have the discipline.  I graduated with my Masters in Quality Assurance in December of 2009, and Edwards paid for the whole thing, not a bad deal!  Another accomplishment to add to the resume!  Also in 2009, I had the good fortune to meet Emile Pinsonneault, who was working as a Director of Quality at Edwards, having just moved from Florida.  Through our mutual love for music, we became fast friends, and we have kept in contact ever since.  For our musical exploits, you can check out my blog post “For the love of music, drums and lifelong friends, part 2”, which details all the bands we were in together, and where we played over the years.  Super fun!         

However, toward the beginning of 2011, I had enough of my paranoid boss (the only male manager I have ever had at Edwards; we had actually worked as peers at Micro Therapeutics, Inc., and I got him the job at Edwards), primarily due to a culture clash, and his micro-managing style.  Toward the end, I even told him “I can’t work for you anymore”; he was the only manager I have ever had that wanted full access to my Microsoft Outlook, so that he could see what meetings I was attending, and with whom.  I can’t work like that!

Edwards Lifesciences, Irvine, CA:  Regulatory Affairs Professional, spring 2011 through August 2023.

In the spring of 2011, I had the very good fortune of getting hired as a Regulatory Affairs Professional with the same business that I was supporting as a Quality Engineer, and since then, I have never thought of doing something else.  This was an alignment of the planets; the Regulatory Affairs management at the time had an idea that they wanted to hire some engineers and train us to be Regulatory Affairs Professionals.  So, there I was at the interview; I had brought along my Masters Thesis from CSUDH, which, incidentally was, at 270 pages, the longest thesis they had ever seen.  I put the thesis on the table in front of the Vice President of Regulatory Affairs and I said “I like to write”, and I got the job!  By the way, if you wanna go to work as a Regulatory Affairs Professional, you gotta love to write, it goes with the job description!  Long story short; in my almost 13 years at Edwards working in Regulatory Affairs, I’ve always had a great boss, generous pay, interesting work, and the respect of my peers.  Like I usually say “it is better to be stupid and lucky, than smart and unlucky!”  Don’t get me wrong, working in Regulatory Affairs is no picnic; we are usually known as the department of No!!!!  Whenever I describe my work I tell people that it is the easiest job in medical devices; all you have to do is learn how to say “No” with 15 different inflections.  There is the “Oh No”, the “Hell No”, the “Tell Me You Didn’t”, the “Noooooo”, the “Over my dead body” No; you get the idea.  However, I earn my keep when I sit in meetings with nine other people that are all saying “Yes, Yes, Yes” and I’m the only one that says “(and you guessed it) No!”  By the way, not to make it sound bad, but you will never see a Regulatory Professional get voted Employee of the Year at a medical device firm; we are just not that popular…

In 2013, a whole bunch of stuff started happening; in addition to my work at Edwards, I also started as a volunteer instructor and presenter at the American Society for Quality, section 701 (the Orange Empire section).  I taught classes in quality systems and quality management, and I presented on process validations.  Also, in the summer I started working on my Masters in Regulatory Affairs, a fully on-line program at San Diego State University.  Like before, Edwards paid for the tuition, not a bad deal!  I eventually graduated in December of 2015 with a Masters Degree in Regulatory Affairs; again, more stuff for the resume!  In my opinion, if your employer pays for continuing education, why wouldn’t you take advantage of that policy; education never hurts!  (And to show you how we are all connected in the medical device industry, especially in Orange County, the current faculty director and graduate advisor for the Masters program in Regulatory Affairs at SDSU is Kim Walker; I worked with Kim at AcuFocus in 2005-2006…).           

San Diego State University, 5500 Campanile Drive, San Diego, CA.  In my opinion, this is probably the prettiest of all the California State Universities…

 2014 was reasonably uneventful; just working away at regulatory submissions and whatever else, but toward the end of the year Edwards reorganized, and one of the smaller business units, located in Draper, Utah, was absorbed into “my” business unit, Heart Valve Therapy.  So, by the beginning of 2015, I was providing regulatory support for a line of catheters that are used cardiopulmonary bypass, known as Edwards Protective Cannulae.  2015 turned out to be quite the year; in early 2015 I had inherited one direct report and I quickly hired three more, so by the end of 2015 I had four direct reports, all of them salaried professionals (let me tell you, there is a difference when managing hourly direct reports like I did in 2007-2009, versus managing salaried professionals, who are usually much more vocal and opinionated).  I grew a pretty thick skin in 2015, having to deal with the fall-out from the business unit absorption, and also making sure that my direct reports had plenty to do (always), while at the same time being protected from whatever political upheaval that roiled our business unit.  Also, having four direct reports meant that I was responsible for training, mentoring, performance reviews, salary recommendations and career development, and I think I did a pretty good job, if I can say so myself.    

California State University Fullerton, Fullerton CA:  Adjunct Faculty, Fall semester 2015 through spring semester 2019, teaching undergraduate classes; Operations Management 339 and Quality Management 425.

For some reason, teaching at the university level had been part of my bucket list for some years, maybe because my wife Kathy had been a substitute teacher.  Also, the thought that a former truck driver like myself could teach at a major university like Cal State Fullerton seemed almost fantastic!  However, through a contact at American Society for Quality, I was interviewed by the dean of CSUF College of Business and Economics, and since I had both an MBA and a Masters in Quality Assurance, I was hired!  As I started teaching, there were a few things that I had promised myself that I would do (as opposed to some of the teachers I had taken classes from in the past):

Make sure that the grading system was fair and easy to understand;

Make sure that the results from tests were posted promptly, so that the students would know where they stood in the class, so that they could make the appropriate decisions (stay, drop out, go cry to the teacher, etc.);

After the final, post the final grades ASAP, so that none of the students had to agonize needlessly (there is nothing worse than to take a fall class, and not get the final grade until after New Years…)

Offer some extra credit, so that the students who were struggling could have a chance to pass (this was especially true when I taught Operations Management 339, where I would be more than generous with extra credit; even so, usually some 10% of the class would fail)

I was originally hired to teach Quality Management 425, which was an elective for a business degree, but by the third year I was asked to also teach Operations Management 339, which was a required class for a business major, and one semester I taught both classes, while also working at Edwards.  Fun times!  Since CSUF has a satellite campus in Irvine, I taught most of my classes in Irvine, but I also commuted for some of the classes up to the main Fullerton campus.  Being the ham that I am, I really enjoyed the brick-and-mortar lectures and the interactions with the students, and I really believe that most of us that have “real” business experience can teach, if we have the interest.  Especially teaching Quality Management 425, I used my experience at Edwards Lifesciences as a backdrop, and I was able to relate the book theory to real life, especially since at the time Edwards had adopted pretty much all of the best practices regarding quality.  Nevertheless, teaching at any level is not for the faint of heart, something that I quickly learned.  Being responsible for teaching the syllabus, keeping attendance, grading tests, keeping track of student progress, and finally grading the students requires a lot of bookkeeping, in addition to the actual teaching.  Also, since most of the students are interested in just one thing, that being able to pass the class, I could sometimes feel the indifference from the students which was a bit disappointing.  Even so, the eight semesters I taught at CSUF were very, very rewarding, and I would recommend this sort of part-time job to any professional that has the time and inclination.  But, given the time commitment needed and the relatively low pay vis-à-vis the requirements needed to teach at the university level, after eight semesters I felt I had put in my time, and after the spring semester of 2019 I left my position as part-time faculty at CSUF.  Nevertheless, my fondness for Cal State Fullerton has never wavered, especially since our whole family are CSUF graduates.  Go Titans! 

At Edwards, in early 2016 I was offered two choices from my then boss; number one, continue doing what I was doing, supporting manufacturing and managing my staff, or, number two, start supporting new product development projects.  I chose the latter, and for the next five years I supported research and development as a regulatory professional, working on several R&D projects and the subsequent regulatory filings.  This was a great time; I had the pleasure of working with what I believe was one of the best teams at Edwards, the MITRIS team, and I was able to follow a new product from inception to its eventual market release, from our first initial meetings with the FDA in 2017, though first commercialization in 2020 which took place in Japan of all places.  Don’t be fooled, this involved a whole bunch of work, but with our tight-knit team we were able to meet pretty much all of our milestones, no problem!  Also, since the R&D work is not a steady stream of work, I also worked on other projects, such as supporting our initial European Medical Device Regulation initiative, at one point leading a tiger team in order to make sure we fulfilled the documentation requirements.

Now, March 2020 changed everything; I remember having one of our daily meetings with my tiger team, and some of my team members were worried about this new virus that was going around, and there was a lot of talk, and people were scared.  A few days later, we were all sent home from the office, with the instructions that “we will all be back in the office in a couple of weeks…”.  Oh, how wrong we were! I went home and like many people, I set up a temporary workstation at my dining room using a regular dining room chair and an old borrowed HP monitor, where I worked for the next three months on my MITRIS FDA submission.  I had just started my prostate journey (you can check out that saga on my blog), which made life not so pleasant.  I remember our first Zoom meetings which were chaotic to say the least; however, as time wore on, and Microsoft Teams got perfected, we all started getting used to two-dimensional meetings.  After a couple of months, we started going back to the office every other day, and I remember schlepping a urinary catheter in my backpack for my early afternoon self-cathing session (again, if that story sounds interesting, check out my prostate blog post).  However, as the virus ebbed and flowed, we were sent home again, and after about three months, I set up a more permanent workstation in my living room, complete with a laptop computer docking station and my three monitors.  By now, most of my work friends were doing the same thing, setting up more permanent workstations in their homes, because it seemed like we were going to work from home for a while.  By late 2021, I think we were back in the office again on a part-time basis, but on most days the Edwards Irvine campus looked like a ghost town, with most of the office staff working from home.  However, by early 2022, it seemed like more and more people were returning to the office, albeit on more of a part-time basis (come in late and leave early…).  Nevertheless, in my case I never really returned to the office, but more on that below.  Also, in the beginning of 2021, I was transferred out from my new product development role back to supporting the product line I supported in 2015, our family of cardiopulmonary catheters, for reasons that only became clear much later.  No big deal, a job is a job, and a paycheck is a paycheck, especially if it stays the same. 

However, on March 28, 2022, an announcement was made that Edwards had decided to sell off the cardiopulmonary bypass catheter business and that Edwards expected the sale to be completed by September of 2022.  For us that supported the product line, we would be affected, and most likely be laid off when the sale was completed, which for me, after more than 15 years of service to Edwards, felt like a betrayal.  After the announcement came out, I just so happen to be in the men’s room when our corporate vice president came in, and he asked me “Peter, how do you feel about the announcement?”.  I replied “I feel like a flea that’s at the back of a dog that’s at the animal shelter”.  That was not the reply he was expecting, and he was clearly taken aback, but that was the truth.  Nevertheless, as 2022 wore on, with rising interest rates, the investment landscape had changed, and by the end of 2022, a new decision was made; a new business was to be created that would encompass the cardiopulmonary bypass catheters, which, after this business had gained traction, would then be sold off under its own name.  And so it happened; in the beginning of 2023, a new entity was created; enableCV, a wholly owned subsidiary of Edwards, focused solely on the cardiopulmonary bypass market, and I found myself part of the enableCV team.  In early September 2023, we were officially separated from Edwards, and as of that date I no longer receive an Edwards paycheck, which ended my employment with Edwards Lifesciences.

When I look back at my time with Edwards Lifesciences (17 years), and even though the end was not as I had planned, overall my employment at Edwards has been truly rewarding, both in my professional development and also financially, given our competitive salaries, generous bonus plan and for the most part a positive share price (and a couple of stock splits, thank you very much!).  When I started at Edwards Lifesciences in early 2007, we had some 6,000 employees worldwide, with yearly sales of about a billion dollars.  Fast forward to 2023 (before the sale of the Critical Care business unit to Becton-Dickinson), and Edwards had some 17,000 employees world-wide, and yearly sales of more than four billion dollars, so the growth of Edwards Lifesciences has been phenomenal.  I have had the pleasure of working with some of the smartest and most accomplished people that one can ever meet, and working with and in some truly outstanding teams.  I also prospered in my career, going from a lowly staff engineer in 2007 to Director of Regulatory Affairs in 2023 (even though my last “promotion” from Senior Manager to Director was more of an HR title adjustment than a true promotion).  I hope that in some way I was able to contribute to that exceptional growth, and that Edwards continues to grow and prosper.  However, with Mike Mussallem’s retirement in 2023, and with the share price pretty much stuck around $70.00 since the all-time high of $130.00 in December of 2021, the future of Edwards is somewhat unclear, at least for a simple guy like me.  Also, with the unexpected sale of the Critical Care business unit in June of 2024 to Becton-Dickinson, coupled with (for Edwards) the unprecedented, demoralizing layoffs of some 500 employees in 2024 has left many of us wondering if the Edwards that we knew under Mike Mussallem is gone forever…  Progress, I guess…                    

enableCV, Midvale, Utah:  Director of Regulatory Affairs, September 2023 through now (as of this writing, July 2025).  

In the beginning of 2023, as the plans for the new business started to solidify, I got a new manager, and even though I had early misgivings, my new boss at enableCV has turned out to be a fantastic manager, juggling a multitude of roles, while keeping her large staff happy (you can call me a sycophant, I will not be insulted).  So, what initially looked like a raw deal, has in reality worked out really well for me, and I’m still employed, even though I should have been laid off in September of 2022.  With the formal split between Edwards and enableCV, in addition to being fully remote (no more starched shirts for me!) I have had the good fortune to work on several interesting projects, one of which is the certification of our products under the new Medical Device Regulations in the European Union, a project that has kept me really busy for the last two years.  Since enableCV is much, much smaller than our parent Edwards Lifesciences, we have been able to achieve something that very few people thought we could do, under a very aggressive timeline, due to our ability to react quickly through our excellent team work.  Also, with a small, dedicated team, where every team member wears multiple hats, our ability to “pivot” (a fancy corporate term that describes the ability to change quickly) and find solutions to issues has proven to be one of our core strengths.  As I’m writing this in July of 2025, it appears that we will very soon be sold, which will (with a little bit of luck) usher in yet another chapter in my working life, and hopefully I’ll stay employed for as long as it suits me and whomever wants me!  Working life is still good!