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As originally asked by James Hurst.

I am a PhD chemical engineer with experience in the U.S. printing industry. I think that my experience with polymer materials and processes can be applied in the medical devices industry. I would like your advice on how I can get the attention of medical device employers without the relevant experience on my resume.

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Vincent Nyathi
International Student Office Assistant at Vincennes University
Why not give a start by going attending the January training at BiomedRx Inc..Check it out at [https://learningannex.com/listings/Introduction-to-Healthcare-Technology-Management/scheduled_events/1219|leo://plh/https%3A*3*3learningannex%2Ecom*3listings*3Introduction-to-Healthcare-Technology-Management*3scheduled_events*31219/yMD-?_t=tracking_disc]

Or call Devin Lockett at 424 204-2382 for more information. Hope this helps.

Elizabeth Nichols
Sr. Compliance Auditor at Abbott Laboratories
Some medical devices actually using a ‘printing’ type process. For example, the glucose strips that are used with a glucose meter have chemicals printed onto the surface. I suggest trying this type of company for a start.

Santosh Gosavi
Mechanical Engineer for Innovative Idea
Unless you start with marketing for medical devices, it’s very difficult to enter in market. Please increase contacts in same fields. If i will get opportunity to supply then i will also start.

Perry Mykleby
Customer Activation, Engagement & Retention
@ Joanna, I would recommend the following to you or anyone wanting to enter the sector:

> Continue networking. Connect with the most influential people you can, within the companies you’d enjoy working for. You’re off to a good start. Being a part of this LinkedIn group is important. You can also look into joining other well-managed med device groups. I could advise further if you wish.
> Buy yourself a copy of “The New Elevator Pitch” by Westfall. (I have no commercial interest in this. I own a copy myself.) Why? You need to be prepared to tell a potential employer what YOU can do for THEM. Simply saying you want to work in the industry won’t cut it. You need to develop your own “value proposition.” The Westfall text will guide you through that process.
> Find a mentor or two in the med device space, and better yet, in the specific space (in this instance, Spine), who can advise on an ongoing basis.
> Check the Career links of companies you’d like to work for. A good flanker strategy is to connect with people within that firm first, so you can alert them to your interest in advance of applying online.

There are companies out there who have an open mind about hiring from outside. As Martin has said, there are companies who hire clinicians for sales or customer education. Those can be terrific roles.

I hope this is helpful.

Martin Roberts
Domestic & International Medical Sales & Management Entrepreneur.
Joanna, I would contact medical recruiters who specialize in placing clinical specialists that support the sales reps. The money is lower than the rep but once you break into a company you can then be taken seriously if you want a sales role later.

Good luck.

Joanna Ku RN, BSN, MBA
Emergency Room RN, Ben Taub General Hospital
I am a Certified Surgical Tech that specializes in spine. I would like to transition into the medical device industry. In speaking with various companies, what are the most important factors to weigh in? Foot in the door? Opportunity? Company reputation? Any advice?

Mark Ellis
Head of Nursing Recruitment at MatchMedics
Networking is the best answer. Talk to people who actually work within the industry. Rather than saying you want to work in the industry, try thinking more specifically about the type of role you feel you would like to undertake and make a list of organizations. Talk to people within those organizations who work in the area where you want to be; they will enlighten you on barriers to entry and what you need to do to overcome them. There is some great advice here but actually talking (or even better meeting) people is much more advantageous.

I give the same advice to graduates as well as those wishing to transfer their skills form another industry.

Perry Mykleby
Customer Activation, Engagement & Retention
@ Andre, There are several possible answers depending on what you mean by “obstacles”.

Rob Packard
510(k), CE Marking & Quality System Consultant
Hi James. You are correct that the cGMPs and Six Sigma methodologies have very much in common. ISO 13485 is another piece you will need to learn, but all three are processes for improving quality and quantitatively ensuring that medical devices are safe and meet the intended performance requirements (CTQs).

With regard to your job hunting…you might consider taking an introductory course on the QSR (21 CFR 820) with AAMI.org. Recruiters seem to get copies of those attendees lists every time–and the course will help you understand cGMPs and ISO 13485 better.

PS – I’m a ChemE too.

David Buzzeo
Senior Level Global Sourcing |Procurement|NPI Support
I agree with Dave Hunt above – Network. Find a medical deviCe industry organization in your area or go to a Medica device show. There is Meddevgroup.org in the Boston area. Maybe they have an affiliate in your area. Good Luck.

Daniel C. Driver
3500+ LinkedIn connections | Truck Driver for Usher Land & Timber, Inc. | Transportation partner with Uber & Lyft
How would I be enabled to become a transportation partner in the medical devise industry?

Currently, I am working as a RateMyShipment freight agent for Roadrunner Transportation Services.

Olivia Longley
Manufacturing Engineer III at Lightspeed Aviation
Hi James,
You should consider stent graft manufacturing companies that use both nitinol and polymers in their products.

Jim Morrisey
CEO at Transition to Serve, next chapter
James, if you had experience with nitinol, I would have an interview for you right away with a medical device client. Timing, keep up your networking and get a copy of “What Color is your Parachute”. Helps you think through what you are really good at doing and how to present that focus to others. Jim

Tammy Nguyen
SQE at Powerwave Technologies
I am a SQE. I’d like to enter medical device industry since I think that I can learn a lot in this field and it is a strong and stable industry. But I have never worked for a medical device company. Any advice?

Andre’ Nel
Engineer at IMAC Systems, Inc.
I also want to enter the medical device industry. I feel my skills and experience are directly transferable.

On a side note, I am looking through the regulatory requirements. In terms of project management, I just see them as part of the deliverables for any product development project. How the deliverables are met is greatly dependent on the device.

What is the major obstacle in meeting regulatory requirements? Is it interpretation?

Kenneth Bassett
2019 Goal – Certified Quality Manager ASQ
Hmm… In my schooling I didn’t think they were very similar. cGMP is used in this industry to produce a product the same way every time, a product can be a good product but the company failed to use the cGMP guidelines so the product will fail. Six sigma is a statistical approach to quality control in which the company continually tracks and trends aspects that can be related to the quality of a product, in which the result is cutting down the variance in parts produced so drastically that there is essentially a 0% likelihood you will get a nonconforming part (a goal, not a real life practice, if I remember right even Motorola only got down to 4 or 5 standard deviations).

Compare failing and nonconforming part types. Failing means that part does not get sent to the consumer, nonconforming means not within specifications, but not necessarily failing.

James Hurst
Materials Engineer at General Motors
I have a followup question inspired by my personal study of the cGMP practices that are required in the medical devices industry. Are there any group members who are conversant in both cGMP and in Six Sigma practices? It appears to me that the two have much in common. Could you please compare and contrast the two quality methods for me?

Todd Staples, MBA
Account Representative, GYN at Medtronic
James, You are fortunate to live where you do actually in this regard. UB has a newly established COE in Material Informatics, which is closely tied to the UB COE in Biomedical Sciences which as you probably know houses a couple dozen small med device startups. These two centers of excellence share many resources at UB and being affiliated with either one would open resources at the other. These COE’s locally collaborate with industry all across western New York, so I would make a few connections in those circles and see where that takes you. There are countless networking events here in western New York each month as well. Good Luck!

Perry Mykleby
Customer Activation, Engagement & Retention
Agree with Jon.

Med device could use more “outsiders” getting involved. I think we could learn from industries that have been more cost constrained–or maybe even more innovative–than we have been. Besides, we all started from “scratch” at some point.

The best med device engineers I’ve worked with recently came from consumer electronics, hardware, and automotive.

Santosh Gosavi
Mechanical Engineer for Innovative Idea
You should not enter,If you don’t have the engineering knowledge and designing knowledge of medical devices.