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As originally asked by Rungun Nathan.
Basically I am a mechanical engineer (controls), with background in designing and building electronics, testing them and I am fairly good in computer and micro-controller programming. What other knowledge or background would one need to be able call oneself a “medical device engineer”?
The skill set for a laser or electronic device will be different than for a mechanical device. An implant will have different requirements for different parts of body, and therefore, will require different and varied skill set.
Do you enjoy research? Are you familiar with the bio-compatible materials? How about the National Standards (these can be from many different organizations)? Do you know anything about approval procedures? About notifications? About quality criteria and reliability? Sterility requirements? GMP or Good Manufacturing Practices?
Enjoy. It takes lots of patience, perseverance, insight, intuition, focus, and will power. Your credentials are obviously great Now you need to educate yourself more (either in a formal setting or on your own), and start small. O yes, and do not overlook patents and patented processes.
Daryl Mullins PMP, CSM, MBA, BSEE
Download the PDF document entitled Design Control Guidance. it’s from 1997 and is very useful in understanding what the FDA wants in Design Control.
To learn more, see the full certification course work written here:
best wishes in your search for new knowledge that increases your view of the FDA-regulated part of the topic.
George – Thanks for the pointers, I am looking into the topics you have mentioned and I am planning on introducing it the next time I teach this class again.
Pat – I have an organization MEPCIS in my area and have already made contact with them after reading your reply. The President has promised to help me. Ours is small campus and I am offering the course for the first time. I am trying to reach out to all of you so I can introduce relevant topics in future in this course. Simultaneously I am attempting to make my students aware of current trends.
Tony – Sorry about the grammatical error in the question.
Scott – I will look into the ASQ courses.
Charles – Thanks for giving me the specific document in FDA.
I’m a field service engineer with 12 years of onsite field experience with the same
Pat Ridgely, MD
I am a faculty and was wondering if there is any place I can work as an faculty intern during the summer to learn the ropes or tricks of the trade? Any pointers or contacts will be great.
thanks folks – I am glad I joined this discussion group
Pat Ridgely, MD
Rungun, go ahead an apply for jobs if you want to work in med devices. When I started into my first med tech job I had zero medical devices experience, learned it all there. The most important thing is to be willing to work in a very structured way and to standards. It is not much different than aerospace, for example (I work in both fields). Smart companies will not restrict their hiring to people with proven med devices background, at least not for all jobs. If they do then maybe you don’t want to work there anyhow 🙂
Pat Ridgely, MD
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