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”?

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thanks David. Actually I have also made a note of the topics and links suggested. It is a great resource – I agree.

David Elliott
Opto-Mechanical Engineer at Optimum Technologies, Inc.
What wonderfully concrete information. Thanks to all for your efforts at lifting the veil on a difficult to penetrate topic. The clarity of your suggestions amid the noise is also appreciated by this engineer still trying to gain sure footing. As part of my perpetual education I have pasted the links and definitions into my notes. I suggest hiring managers take note as well. Finally Kudos to Rungun for focusing on getting in the door of a medical company since a bit of prior medical experience seems the one true open sesame to a career in medical.

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thanks Jagu for your questions and suggestions. Yes I enjoy research and I do have some ideas for medical devices.

Jagu Barot
Design & Development Engineer, Quality Engineer, Manufacturing/Project Engineer
Medical Device Engineer for which device? Are you inventing, innovating, or just supporting a device manufacturing? Are you interested in anatomy, physiology, bio-mechanics, bio-physics? Are you familiar with FDA guidelines/ISO guidelines?

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.

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thanks Manjunath. It seems to be interesting certificate course. It will give me some leads and ideas

Manjunath Makam
Deputy General Manager at Michell Bearings India Pvt. Ltd., (Rolls-Royce JV)
Rungun, my daughter has completed ‘Medical Product Development’ an online course from ‘University of California’ along with her Bachelors in ‘Medical Electronics’. To learn more go through the link, I am sure you will find it useful.

[http://unex.uci.edu/areas/life_sciences/medical_products/|leo://plh/http%3A*3*3unex%2Euci%2Eedu*3areas*3life_sciences*3medical_products*3/FDai?_t=tracking_disc]

Daryl Mullins PMP, CSM, MBA, BSEE
Project Manager | Program Manager | Expertise in Lean, Scrum, PMBOK types |
Rungun, please go to www.fda.gov, click on the Medical Devices tab, go to the middle of that page and down to the Industry Assistance section. There click on Guidance Documents. there in the red search box, enter “Design Control – ucm070642”.

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.
That will get you started in building your perspective.

To learn more, see the full certification course work written here:
[http://www.ucsc-extension.edu/programs/medical-devices/schedule|leo://plh/http%3A*3*3www%2Eucsc-extension%2Eedu*3programs*3medical-devices*3schedule/Yrzq?_t=tracking_disc]

best wishes in your search for new knowledge that increases your view of the FDA-regulated part of the topic.

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thank you George, Pat, Tony and Scott for your replies.

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.

Charles Griswold
Mechanical Engineer/Consultant
The FDA design control requirements are covered under FDA title 21, CFR part 11. It would also be helpful to understand the 510K process (whereby a medical device is argued to be similar enough to previous designs to obtain a waiver by the FDA for more extensive testing).

Wade Miller
Field Service Engineer at Hitachi Healthcare Americas|Open to New Opportunities
With the vast amount of experienced people here on LinkedIn, could some of you folks offer me advice on what I need to do to transfer my skills and experience to enable myself a position in the medical device or medical diagnostics field?

I’m a field service engineer with 12 years of onsite field experience with the same
Type of skills and background one would need to be proficient in the field. IE, electronics, mechanical, vacuum, pneumatics, computer, robotics, and of course customer relation skills. Other than basic hands on with the equipment. Any feedback would be greatly appreciated. Thank you!

Pat Ridgely, MD
Consultant in medical devices and education
Rungun, what sort of devices are you interested in working on: e.g., implantables? Are there device companies in your area? I have often found that leveraging professional society chapter meetings can be a helpful way to make contacts and see what is available in your area. Also, take a look at what biomedical/clinical-engineering programs have in their curricula, and talk to people in those departments. It can sometimes be helpful to just scan the openings listed online at device companies, as that can give you some idea of what they are looking for. Have you talked to the placement service at your school? They may be able to help you identify alumni working in the device world.

George Purtell
Senior NPD Engineer at NextPhase Medical Devices
You certainly can enter the medical device field with a typical engineering background but some additional knowledge and skills are required. You can either get educated in these areas or learn on the job. As others have mentioned an understanding of design control and the regulatory environment are most important..Some knowledge of anatomy and physiology is helpful. This is particularly true as it pertains to the specific devices that you are working on. Knowledge of where it is used in the body and knowledge of the hospital environment that it is used in is important. Catheter labs, surgical suites, etc all have their individual nuances that you need to learn in order to do a good job of defining user requirements for your products.Other areas you may wish to learn about are biocompatability of materials and biococompatability testing requirements, Another important area is methods of product sterilization such as Eto ebeam gamma etc. Each method has its own pluses and minuses depending on the product and its applications.Also, knowledge of shelf life testing and 2 x sterilization is useful. These are just a few suggestions of areas to learn . I hope this helps

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Joerg and Pat – thank you both for the suggestions. Right this moment I am looking at what are the tools/education needed. From what both you say – I need to have some good idea of regulation, then I need to have some idea of design control. It also looks like I need to become meticulous with record keeping.

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
Consultant in medical devices and education
Joerg, I did not say that companies should only hire engineers with med-device background. I was only giving a personal-opinion answer to Rungun’s original question, which was what else one needs to be able to call onself a medical-device engineer. I have certainly seen engineers from other areas be successful in devices, though my experience is that this is not always an advantage. (Similarly for military background: I have seen it be an advantage and a disadvantage, depending more on the person and the situation.) Rungun, I certainly agree with Joerg that you should apply for med-device jobs that match your interests and skill-set.

Joerg Schulze-Clewing
Electronics Design Consultant
Pat, that can also go the other way. When in need to streamline production we hired several aerospace engineers into a med devices company. Best hiring decision I ever made. Engineers from outside medical have a broader background in other directions, they can bring fresh ideas to the table. I have also had good experience with people from a military background. They can usually organize and manage very well, won’t cave in under stress, nothing falls through the cracks, and that’s important in a heavily regulated field such as med tech.

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
Consultant in medical devices and education
Not sure I can quite articulate this, but to me there is a difference between a medical-device engineer and a controls engineer working in the medical device area. I know that may sound like pure semantics, but I don’t intend it that way. (Nor do I mean it in any way as a slam on controls engineers!) Putting my hiring hat on, the “medical-device engineer” tag to me conveys a broader background and experience beyond just controls.

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thanks Daniel for additional details. Please correct me if my understanding that NPD stands for New Product Development. I will get the Teixeira’s book and read it.

Daniel Feller
Director, Design Assurance
To compliment Erich’s suggestion (assuming this is an NPD engineer), I would also add basic statistical quality and reliability tools, change control, and design transfer to the list. Knowing when concept and feasibility design ends and design control begins is important. Concept and feasibility is not within the scope of design controls. I would expect that a design engineer to spend most their time in that space. Teixeira’s Design Control book is a great reference!

Rungun Nathan
Associate Professor & Program Chair (Mechanical Engr) at Penn State Berks. DJ for Sangeet (WPRB)
Thank you Erich. From what I understand from your information – I really need to look at the regulatory parts. I will look to see if there are any white papers or documents on FDA about design Controls etc. Thanks again

Erich Coiner
Mechanical Engineer
You need to understand what the FDA requires for Design Controls.
It covers the usual project development steps but with a high focus on Hazard analysis and documenting how decisions are made.
Having worked for many years in a consumer products environment, stepping into a medical device company was eye opening.