About the Program
The Healthcare/Life Sciences sector will be one of the
sectors which will continue to generate jobs in the US in the future. In this
article, we will specifically focus on career opportunities in the medical
device industry after an MS in Biomedical Engineering.
The MS in Biomedical Engineering is a great choice for
students and prepares students for the various roles in the medical device
industry. In this article, we will talk about some of the career options available
to an MS in Biomedical Engineering graduate in the medical device industry.
Engineering roles in R&D/Product functions of medical
device companies is a great career path for a graduate from an MS in Biomedical
Engineering program. Product Development Engineers or Project Engineers help
bring a product from concept to launch which following a comprehensive design control
methodology. The US FDA has outlined around the design control requirements as
part of it’s guidelines for the medical device industry (21 CFR 820).
This standard (21 CFR 820) outlines a comprehensive approach
to verification & validation when bringing a medical device product to
market. Product Development engineers spend considerable time understanding
clinical challenges faced by doctors and hospitals and use that Voice of
Customer input to drive their design thinking when bringing a product to
Product Development Engineers also use advanced simulation
techniques like Finite Element Analysis (FEA) to predict failure and risk in
medical devices during the design process.
This is another area where biomedical engineers are a great
fit for in the medical device industry. In the medical device industry,
manufacturing engineers work very closely with R&D to ensure that a “Design
for Manufacturability” thinking is incorporated in the product development
Now, why is “Design for Manufacturability” important? This
is because when you design a product, you need to make sure that your
manufacturing process can make the design that you have created. For example,
if you are designing an implant, can your manufacturing process hold the
tolerances specified on the print.
Another area where manufacturing engineers also play a key
role in manufacturing equipment validation in the medical device industry where
they ensure that the manufacturing process is able to produce devices as per
the design specification in a repeatable and reproducible manner. This is again
another key requirement of the FDA Regulations (21 CFR 820) for the medical
In addition to the above areas, manufacturing engineers
continuously work to continuously improve the process efficiency of the
& Quality Systems:
This is another area where biomedical engineers are in
demand. The medical device industry in the US is governed by very strict
regulations that have been put together by the US FDA. The US FDA regulations
cover all aspects of medical device industry (Design Controls, Supplier
Management, Training) and is called QSIT (Quality Systems Inspection
Biomedical engineers can be hired for both Quality
Engineering and Quality Systems roles. Quality engineers broadly make sure that
all your verification & validation requirements are met during the design
and manufacturing process. For example, have all the processes outlined in the
design control requirements been followed, have all the equipment & gauges
been calibrated as per requirements, are the suppliers chosen to design,
manufacture a product capable of meeting the organization’s standards.
Nowadays, software has also become an essential component in
medical devices. The US FDA also regards software development as a equivalent
to manufacturing a device and has established strict guidelines around the
software development and testing processes to be followed for medical devices.
Apart from software that is actually a component of a medical device, even all
IT systems used in a company have to be validated as per the FDA’s guidelines.
In short, Quality engineers play a very important role in a
medical device company and this is another area where a biomedical engineer can
get hired after completing their MS.
The MS in Biomedical Engineering program in the US provides
very interesting career options for students who graduate from the program in
the medical device industry. This is an industry that will continue to grow and
needs skilled engineers to continue to innovate and bring life changing devices
If you have any further questions about the MS in Biomedical engineering
option, please feel free to reach out to us and talk to one of our Academic