How to get into an R&D Engineering job (Medical/Biotech)?

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SUMMARY

To enhance prospects for R&D positions in the medical devices and biotechnology sectors, undergraduate engineering students should focus on relevant majors such as Mechanical, Electrical, or Bioengineering. Engaging in undergraduate research, pursuing internships, and gaining experience in regulatory affairs are critical steps. Understanding FDA regulations, Good Manufacturing Practices (GMP), and design control processes (21 CFR 820.30, ISO 13485) is essential for career advancement. Students should also consider pursuing a Master's degree in Mechanical Engineering to improve job prospects in product research.

PREREQUISITES
  • Knowledge of FDA regulations and approval processes
  • Understanding of Good Manufacturing Practices (GMP)
  • Familiarity with design control standards (21 CFR 820.30, ISO 13485)
  • Experience in undergraduate research or internships in medical device companies
NEXT STEPS
  • Research internships with medical device or biotech companies to gain practical experience
  • Learn about regulatory affairs and its importance in the biotech industry
  • Pursue a Master's degree in Mechanical Engineering with a focus on biomechanics
  • Investigate startup opportunities in biotechnology and understand commercialization processes
USEFUL FOR

Undergraduate engineering students, aspiring R&D engineers, and individuals interested in careers within the medical devices and biotechnology sectors.

WK95
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What can I, as an undergraduate engineering student, do to increase my chances of being able to get into a R&D job? I'm interested in working in the medical devices or biotechnology industry.

Besides doing undergraduate research, what else can I do?
 
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WK95 said:
What can I, as an undergraduate engineering student, do to increase my chances of being able to get into a R&D job? I'm interested in working in the medical devices or biotechnology industry.

Besides doing undergraduate research, what else can I do?
It depends on the research one hopes to accomplish.

Ostensibly, as an engineering student, one would major in Mechanical or Electrical engineering, or Bioengineering/Biophysics. The major would depend on one's interests, e.g., R&D in prosthetic devices or artificial strucutures (bone/joint replacements), medicine delivery (electronic) devices, or . . . .

http://www.fda.gov/MedicalDevices/ScienceandResearch/default.htm

One should also consider courses/research in materials from a structural performance and biocompatibility standpoint.
 
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Get into regulatory affairs. Jobs tend to be much more stable than the research aspect at many biotech firms. Biotech is a field that is NOTORIOUS for job losses and job instability. Regulatory affairs people tend to weather the storms better than pure scientists and researchers. They can find work with less effort the more they gain experience. RA experience also opens the door later on to fields like consulting, which pay big bucks. Learn how the FDA and approval works. Understand GMP practices and all of the paper work that goes into it. Learn to analyze market potential.


Most researchers will not be getting biotech jobs at behemoths like GE, Medtronic, Amgen, GSK, etc., so job loss occurs more often. Competition for the menial amount of jobs that open up at those places every so often is insane.
 
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I'm not interested in stuff like consulting or regulatory affairs. If competition for research jobs in those big companies is that much, maybe I should consider academia. Though I'm not keen at all about the idea of teaching. If I'm really ambitious, maybe I could do that and even start my own company.

I'm really seriously considering a career in academia. One of the professors at my university actually was able to produce a medical device that his company is now selling. The device was based on his research. It'd be great if I could do something like that.
 
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Astronuc said:
It depends on the research one hopes to accomplish.

Ostensibly, as an engineering student, one would major in Mechanical or Electrical engineering, or Bioengineering/Biophysics. The major would depend on one's interests, e.g., R&D in prosthetic devices or artificial strucutures (bone/joint replacements), medicine delivery (electronic) devices, or . . . .

http://www.fda.gov/MedicalDevices/ScienceandResearch/default.htm

One should also consider courses/research in materials from a structural performance and biocompatibility standpoint.

I'm planning on minoring in Biomaterials. The reason that I am majoring in Mechanical Engineering is because I'm interesting in prosthetics and such. I'm also a bit interesting in artificial organs so fluid mechanics would come in handy too.
 
WK95 said:
I'm planning on minoring in Biomaterials. The reason that I am majoring in Mechanical Engineering is because I'm interesting in prosthetics and such. I'm also a bit interesting in artificial organs so fluid mechanics would come in handy too.

If you are interested in working in areas like prosthetics or other aspects of biomedical engineering, my suggestion would be for you to at least pursue a MS in mechanical engineering and work for and apply in private companies that specialize in product research in biomechanics.

I used to work as a statistical consultant for an engineering company that specialized in robotics and automation that was a spinoff of my alma mater's mechanical engineering department. To my knowledge, many engineering profs or their graduate students have set up start-up companies that are spin-offs of their area of research, so I'm sure you should be able to find something there.
 
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StatGuy2000 said:
If you are interested in working in areas like prosthetics or other aspects of biomedical engineering, my suggestion would be for you to at least pursue a MS in mechanical engineering and work for and apply in private companies that specialize in product research in biomechanics.

I used to work as a statistical consultant for an engineering company that specialized in robotics and automation that was a spinoff of my alma mater's mechanical engineering department. To my knowledge, many engineering profs or their graduate students have set up start-up companies that are spin-off of their area of research, so I'm sure you should be able to find something there.

Luckily, my university offers a 4+1 program for Mechanical Engineering so I'll definitely try to take advantage of that.

Also, if not do outright R&D at some company, I'm considering Academia where I could possibly create a startup. My university has "commercialization fund" for Biotechnology that is intended to help professors bring thing research and develop it into a product or service.
 
gravenewworld said:
Get into regulatory affairs. Jobs tend to be much more stable than the research aspect at many biotech firms. Biotech is a field that is NOTORIOUS for job losses and job instability. Regulatory affairs people tend to weather the storms better than pure scientists and researchers. They can find work with less effort the more they gain experience. RA experience also opens the door later on to fields like consulting, which pay big bucks. Learn how the FDA and approval works. Understand GMP practices and all of the paper work that goes into it. Learn to analyze market potential.


Most researchers will not be getting biotech jobs at behemoths like GE, Medtronic, Amgen, GSK, etc., so job loss occurs more often. Competition for the menial amount of jobs that open up at those places every so often is insane.

Most of the people I know who work in regulatory affairs (based on my experience in the pharma sector) had originally started out working in the research aspects of the work before working in their current field. I'm not sure how easily one can find work in the regulatory affairs area fresh out of school without prior experience in some other aspect of the field.
 
A skill useful in the medical field that I have never seen taught anywhere is design control. Design control is the process whereby you document the design of the medical device. This comes from the US regulation 21 CFR 820.30 and also the international standard ISO 13485. Usually you learn this on the job, but if you were familiar with it you would be considerably ahead.

Have you looked into internships with medical device or biotech companies? This is an excellent way to gain experience in your field, and it helps you build a professional network as well.

Something else you may consider is getting your foot in the door at a company by taking an entry-level engineering job, probably in manufacturing support. I worked for three years in manufacturing support before I moved into product development.
 
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WK95 said:
Luckily, my university offers a 4+1 program for Mechanical Engineering so I'll definitely try to take advantage of that.

Also, if not do outright R&D at some company, I'm considering Academia where I could possibly create a startup. My university has "commercialization fund" for Biotechnology that is intended to help professors bring thing research and develop it into a product or service.

Getting involved in a startup sounds great, but ALWAYS keep in the back of your mind that if you simply removed the top 10 biotech firms from the industry, biotech as a whole loses about $6 billion dollars per year. Many, many, many extremely intelligent people have tried biotech startups and have failed. Ask yourself, what will make you different? What is your endpoint/exit strategy? If you are small you can probably forget about taking a product all the way from idea to commercial product by yourself (diagnostics or instruments may be easier though since it doesn't go directly into a patient). Always have plan B, C, D, and even E, with the assumption that you will fail. At least it looks good on your resume that you can say you started a company.

You may scoff at RA and consulting now, but always remember that regulatory comply HAS to be done on this soil, so it is harder to outsource RA jobs.
 
  • #11
StatGuy2000 said:
Most of the people I know who work in regulatory affairs (based on my experience in the pharma sector) had originally started out working in the research aspects of the work before working in their current field. I'm not sure how easily one can find work in the regulatory affairs area fresh out of school without prior experience in some other aspect of the field.

I used to work in Pharma as well. It may take experience before you can crack into it, but planning to stay in R and D for long career is terribly misguided these days with the horrendous job stability biotech is known for with R and D staff.

Where I used to work we used to have summer internships all of the time in our RA department, which is one way you may be able to crack into it.
 
  • #12
gravenewworld said:
I used to work in Pharma as well. It may take experience before you can crack into it, but planning to stay in R and D for long career is terribly misguided these days with the horrendous job stability biotech is known for with R and D staff.

Where I used to work we used to have summer internships all of the time in our RA department, which is one way you may be able to crack into it.

I had worked as a biostatistician in clinical research, which is notably separate from the R & D department, so perhaps my perspective is a little different from those who work with the bench scientists. Where I used to work, the main summer internships were in manufacturing/production, with a few in clinical as well. The RA department didn't offer too many internships from my recollection.
 

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