Automotive to Medical Device

[Hektor]

Hello everyone,

I am reaching out for guidance as I plan a career pivot from the Automotive to Medical Devices.

I have 11 years of experience in Supplier Quality and Development Engineering within the automotive industry.(Mostly OEM). Due to the significant volatility and restructuring currently impacting the automotive industry in Europe, I was recently laid off and am now focusing on the more stable Medical Device. (I would appreciate your thoughts on this)

I understand that the ISO 13485 shares a significant overlap with my IATF 16949 / ISO 9001 background, especially in terms of supplier management, auditing, and corrective action processes. I plan to close the regulatory and documentation gap by pursuing targeted training and certifications.

My Questions to the Community:

1. What is the most cost-effective path (low-cost online courses, self-study resources, or specific training providers) to gain a recognized certification or competency in ISO 13485 or FDA regulatory knowledge? I need to be mindful of expenses given my current status.
2. From your experience, how do employers in the Medical Device industry view 11 years of Automotive Supplier Quality experience? Is this experience considered a strong asset or not ?

Any advice, especially from those who have made this transition, would be greatly appreciated.

Thank you in advance for your time and insights.

 

[ChrisM]

I worked in Automotive, then Medical Devices, then Aerospace. Basically so long as you find a "switched-on" employer you should be absolutely fine. You can get free information of the internet about the difference in Standards - look for ISO13485 for Medical Devices - and if you want to maybe give yourself a head start at the interview stage, sign up for an ISO13485 internal auditor course (but IMHO this should be unnecessary and a decent employer will place you on such a course not long after you start work with them).
11 years of supplier QA experience in automotive is effectively 11 years of experience in Medical Device supplier QA although obviously you will need to come to term with the differences of what is "important", for example and from memory, traceability and supporting documentation is likely to be more relevant with medical devices than automotive.

As to making the move - my thoughts are (sadly) that this is the right way to go. I feel that the European politicians have handed car production to the Chinese with the focus on electric vehicles. There was already over-production of passenger cars in Europe and I can only see things getting more dire for European car factories over the next decade or two. Medical devices however are different as there will always be demand, likely to increase as the population ages, and standards should always remain high.... salaries are generally better in the medical arena too. The biggest issue I had to come to terms with was the speed of life, in automotive you are constantly on your feet to make sure that production continues to meet delivery targets, partly because of the financial penalties of failure, whereas medical devices are typically produced at a slower rate and everything has to be right (and every issue properly investigated and documented).

I wish you luck and success with your planned move; don't be afraid to come back here and ask for more help or advice if you think you need it

 

[John Predmore]

Like @ChrisM, my career path was Automotive Quality Engineer, then Med Device, and ended up Aerospace. Like Chris, I was fortunate to be hired into the Med Device industry. Before that lucky break, I applied to dozens of Med Device job openings with 30 years Auto QE experience, but I was out of work for 18 months (during the Great Recession of 2008-2010 and I didn't want to relocate). In job interviews, the Med Device hiring managers would tell me I lacked experience in a regulated industry (they meant the FDA). I would tell them Automotive is heavily regulated by both the EPA and the NHTSA. But (I surmise) they considered Med Device industry is profoundly unique and didn't want to take a chance on an outsider. After my lucky break, the door was forever opened and after I moved on I was quickly hired at 2 different Med Device firms.

From the vantage point of hindsight, IMO the regulatory environment and federal/international quality standard(s) in Med Device are not really more strict or demanding than Auto. But there are differences in emphasis, so you have to enter new environments with eyes fully open, a solid grasp of fundamentals and a sense of humility. Twenty years later, MDR and FDA are becoming more unified with ISO quality requirements, and from what I read, the IATF industry is more demanding now. My experience entering ASD is similar, there are some key differences in emphasis, but overall, nothing far beyond what we were doing in Auto 20 years ago. I am retired now, so I can't say what the job market is now.

As far as advice to @Hektor, spend lots of time in the Elsmar Cove forums to learn the unique jargon, challenges and emphases. I became a member of ASQ when I switched industries, and there are a wealth of resources there. I took the certification exam, and I think professional credentials matter in a competitive job search market. You can also make connections and do research in articles on LinkedIn. To break into any new field or new industry, being well-networked helps open opportunities.

 

[Sidney Vianna]

Thank you in advance for your time and insights.

Just one request, please: DO NOT use the term CAPA. Ever.

 

[GSzabo]

I started my career in automotive and pivoted (after a couple detours in other industries) to med device about 10 years ago. From a technical perspective, your 11 years of experience in automotive makes you more than capable of taking on a supplier quality role in med device. I echo @John Predmore's thoughts though; generally speaking, there is this notion that I've seen in the med device industry that they are profoundly unique and experience in med device trumps ENGINEERING experience and even technical knowledge (I may be generalizing here, but I've seen it happen in med device much more than in other industries.)

The med device industry is not unique in terms of engineering challenges. The same exact concepts of quality engineering, and engineering in general, apply as in automotive or aerospace or any other industry. What makes the industry unique is the terminology they use (examples: IQ, OQ, PQ, TMV), but again, the underlying concepts are not unique. With that said, getting familiar with the terminology should be on your list of things to do. Once you are able to use med device jargon and show what you've done in automotive directly relates to those med device terms/activities, you will have a much easier time convincing your interviewer you already have the experience they are asking for.

 

[Hektor]

Thanks a lot for all the replies. I honestly didn’t expect this level of detailed and thoughtful feedback, so I really appreciate everyone taking the time to share their experiences.

As I understand the biggest challenge for me right now is the “outsider” perception. I can see that I need to get familiar with the Medical device terminology and the documentation style. Actually I’ve been going through some online courses already, but they’re all pretty basic, so I was honestly getting bored and struggling to stay motivated. After all of your feedback, I get that I need to push through the fundamentals first.

Thanks again to everyone who replied, your comments really helped me get some clarity.

 

[Miner]

For the record, I am not coming from a med device background but wanted to add support to knowing the terminology. I went for an interview that started off badly because the person led with the fact that my resume did not show any experience in their specific product. However, I was able to immediately turn it around by using terminology specific to their product and showing the connection between processes that I did have experience with and same/similar processes used to make their product. I ended up getting the job.

Learn (and use) the terminology and make connections between your experience and their needs.

 

[Bev D]

In addition to @Miner’s advice I will reiterate what Sydney said: never ever ever use the term CAPA. It is simply regurgitating lazy terminology that signals a savvy interviewer that you too are regurgitating a term that you do not understand.

I went from semiconductors to automotive to aerospace to medical devices. They are all the same with only minor deviations in regulatory details and seemingly major deviations in terminology. (Primarily the terms hazard and risk) BUT the key is that the rules of physics and human behavior are the same in every industry. This is the key - relate that you know these two things and how they apply in medical devices.

 

[Tidge]

My Questions to the Community:

1. What is the most cost-effective path (low-cost online courses, self-study resources, or specific training providers) to gain a recognized certification or competency in ISO 13485 or FDA regulatory knowledge? I need to be mindful of expenses given my current status.
2. From your experience, how do employers in the Medical Device industry view 11 years of Automotive Supplier Quality experience? Is this experience considered a strong asset or not ?

IMO, personal certification isn't really needed... and there isn't a meaningful "13485" or "FDA" personal certification. AAMI offers some 'certificate' classes (which aren't bad), and ASQ offers generalized CQE certs. The CQE isn't bad... but the medical device industry has some specific regulatory requirements that don't gel with the baseline CQE Body of Knowledge. The areas of difference are primarily evident in the concept of risk(*1)... however someone who groks the BoK for CQE would be a fine Supplier Quality type for a medical device manufacturer.

In practical terms: Automotive Supplier quality tends to tolerate things like "running production changes" and sometimes expects "bullying through orders" that is typically not the case with medical device manufacturing. "More regulated" has a practical meaning that for medical devices "changes have to be verified as effective prior to implementation", whereas "some sucker buying whatever rolled off the line" is often good enough for auto.

Having written the above... it isn't uncommon for (CMMI immature) medical device manufacturers to look for Supplier Quality folks to be miracle workers that can get suppliers to provide materials with incomplete specs, on short time tables, at low cost.

(*1) The BIG difference in quality for Medical Devices vs. automotive is that in medical device is that (verbalized) risk analysis is entirely patient/user-focused.

 

[Bev D]

“whereas "some sucker buying whatever rolled off the line" is often good enough for auto.”
…not in my experience (unles you think you’ll never get caught). While Automotive isn’t as strict as aerospace or medical devices in valdating changes, they are draconian when something is caught. I fit is caught on-line the supplier is dragged in to clear the line and is charged for the downtime….and i fit’s a warranty problem you get bullied and charged and mus tpay for clearing the field.

On the other hand the Auto companies themselves hide defects that cause warranty (behind denial or hidden warranties) and resist recalls at all costs. So they aren’t all that quality conscious themselves. But boy do they like to blame the supplier.