Your Ideal Entry Level Candidate for Medical Device Product Development

It's such a specialised field, I'd be surprized if anyone can be very productive in their first year.

I worked designing instrumentation in the respiratory field.
My biggest initial asset was was probably not knowing anything about the subject, however the medical area is soooo conservative I had to design what I was told to.
I was at the company for about 12years...once I'd left they bought in a design which was of the type I'd been stopped from working on at day one .

You need the same as any other engineering field...the willingness to question the received wisdom coupled with the ability to learn, enthusiasm, curiosity, a good smattering of electronics, mechanical, biology, chemistry, the ability to leap tall building (with a short run up). Oh, factor in some higher maths, assembler level programming (C and visual basic too... ).
Common sense, an appreciation of materials and processes (injection molding, machining etc)

Sense of humour, ability to schmooze the sponsors, accountants etc.
Sharp claws for very occaisional use

(Female gender would make a refreshing change too...)

Del _{(Do I get the job?... I'll wear ladies clothes if it helps)}

Not bad Del,

You will be happy to know that more females are attracted to Biomedical Engineering and Biomedical Engineering Technology field than nearly any other engineering field. I would have to agree with you that it does take some time to absorb the regulatory information that is needed. Assuming you meant to say "bought" it certainly seems that corporations sometime give more credence to ideas brought in from the outside at times.

Thanks for the input,

MPD

I have a little experience in medical devices, so I'll throw in my two cents:

I took very little theory to the field, By that I mean that, in the field I worked in - balance disorders, most of the "experts" came out of other fields, e.g., gun platforms. We all had to learn enough physiology to do the work, but that was frankly kid's play compared to say, signal conditioning. None of us ever knew much about the biochemistry side, but we really didn't care.

So, were it me, I wouldn't hire an entry level engineer. I'd hire engineers who had used similar processes for other fields, and I'd make sure I got a mix of mechanical, electrical, computer, chemical, and material engineers. I'd then send them to a two week seminar on regulatory processes. Then I'd forbid meetings longer than 20 minutes or more often than twice a week. Raises and bonuses would be pegged to a strict, open productivity metric. Accountants, lawyers, and managers would all report to the engineers rather than the other way around. Ultimate authority would rest in the hands of the maintenance person who would be charged with memorizing the mission statement and firing anybody who didn't live it.

Nice!Almost congruent with my thinking re meetings etc.

Actually, I would have a metallurgist/process engineer on the team and send them to do some independent study on state of the biology of materials.

Nice response TVP45.

milo

At least 3 years of medical school with a love for mechanics.

Like the head of the liver transplant unit at the University of Chicago Medical Center.

He started out as a Cummings Engine Mechanic but got bored an needed more of a challenge.

I have worked with Bio Med Engineers and have been their tech support person. They are all great and knowledgable persons but somehow I got the feeling that the general curriculum does not include very much practical stuff in mechatronics and instrumentation and microcontrollers. They were very good at the theoretical and the math/scientific but I met a few that did not know the difference between a PTC and an NTC thermistor.

The best advice I have for you would be to hire an engineer that is young and doesn't know anything about the field but is eager to learn and is knowledgeable in physiology, medical terminology, mechanics and physics. Grow your own!!!

Any IT experience is a big help nowadays because most any medical device can be connected to a hospital network and (I'm guessing here) will probably be required to in the next ten years. The real determining factors in this person would be, IMHO, the resolve to learn, the capability to do the work required, and the ability to take correction very well.

Just finished 15 years working in a device company from day 2. Our first hire came on board with the challenge of taking a concept and making it work and be manufacturable. A very complex concept and mechanism for use within a large blood vessel.

He was hired because--He was very bright-had 10 years experience in product design of non medical parts, and understood really small parts as a result of disk drive experience. The next 5 hires were experienced in medical devices of varied types, mid level, very bright folks. Later hires were both from within and without the device field. Hired based on strengths and at least one solid dose of work experience.

With them as the core, we then brought in interns each summer from Cal Poly. They arrived bright, eager and with some practical teamwork experience. Each was given a project and mentor. Each project was important to the company. At the end of the internship, each student gave a detailed briefing to the design group and then to his school supervisor and class. Some of those youngs kids ended up on patents for which they played a role. More than half of of them were later hired and added to the strength of the group.

As important as the bright kids were, was the management style under which we all worked. The front office folks made sure that we all knew the objective and the timelines we needed to meet. They gave us mid levels mangers that were involved .

They gave us the tools and support equipment we needed and then got out of the way. Periodic huddles of 10 minutes were held to keep the group tuned in to the contributions and problems we all faced.

The company went public quietly but with great success. Five years later they were bought by a major player in the medical business that had no presence in the device field. They tread lightly and gave us more challenges and resources and then got out of the way. More success.

It wasn't until the first generation managers departed over time that the group weakened a bit. This was due to corporate thinking managers in marketing and finance .

Then that group slowly left and a third and weaker group came aboard. Slowly downhill. That first engineer just retired.

Thanks for the great description. I think it is one example of how a successful company gets that way. It also demonstrates the all too familiar degeneration which occurs when the professional corporate types smell money and get a hold of a good engineering/science based company. Once the marketing and finance people get a hold of them you can forget innovation. They squeeze it for profits. It is unfortunately the history of nearly all of our corporations and why small businesses are so vital to our economy.

Did you insist on practical teamwork experience? Could you expand on your company's thinking on that point?

The following skills are essential. in any engineering field.

1) ability to understand, author, and apply specifications

2) ability to solve and manage problems methodically.

3) ability to understand and apply principles of a QMS, aimed at delivering consistency.

4) ability to communicate well with people

5) a reasonable level of competency in your chosen field, and with the tools with which you will work.

6) a willingness (and ability) to learn, and work hard.

chris