Stefanie Heine '91
Senior Quality Engineer
St. Jude Medical, Atrial Fibrillation Division
Position Description:
Ensure adherence to the established Quality System and GMP/ISO Standards. Work with Cross-Functional teams to establish and ensure adherence to measurable product and process specifications. Conduct technical and statistical investigations concerning compliance to specification. Assist in defining and measuring process capability, process controls, and process validation. Address nonconformance and product surveillance issues.
Necessary education or experience:
B.S. degree in engineering discipline. Experience in medical device engineering.
Key skills that are necessary to be successful in your position:
Project management, communication skills (both verbal and written) and problem solving abilities.
A description of your path to your current position:
I started in development engineering, and moved to manufacturing
engineering, with the thought that I would do a better job developing
new products if I understood the assembly process better. I have
enjoyed the involvement with the production of medical products so
much that I have continued to work in manufacturing engineering.
I joined Medtronic in 1997, and have had the opportunity to work
on several transitions of products from research and development into manufacturing. I moved in to Quality Engineering in 2007 at St. Jude Medical, and have had the opportunity to lead process validation efforts and audit team.
Good (and bad) aspects of your current position:
I get to be involved in many aspects of the organization, including development and manufacturing. I also get to be involved in external audits of our organization.
What do you enjoy about your current position?
Interaction with many different departments, including research and development, quality, assembly, personnel, production supervisors, etc. It also is a very fun and interesting challenge to take a design from research and development and develop a
manufacturing process for it.
On MSOE and Biomedical Engineering
Do you think a degree in BE is a good choice?
A degree in BE has been very helpful for me. Having the background in
education relating to the medical field has helped me contribute to my
company in a way that other engineering backgrounds cannot because I
have a greater understanding of how the product will be used.
Do you think MSOE is a good choice of colleges?
MSOE has an excellent program for BE because it covers areas that many
other degree programs at other colleges do not. I also liked MSOE
because of it's smaller campus, which means smaller class sizes. I
feel the MSOE offers an excellent ability for students to have one-on-one
interaction with the instructors.
Why did you choose MSOE's BE program?
I chose MSOE's BE program because of it's emphasis on electrical engineering
courses, and all of the emphasis that we had on the cardiovascular areas.
The other opportunities, such as in clinical perfusion, also drew me to
MSOE - this has been especially valuable to my current position in Medtronic,
working on products used for perfusion.
What did you like about MSOE?
The small campus - I knew almost everyone! I also liked getting to know my
instructors better because the classes were small. The school also offered
many of the traditional "college" experiences, such as the opportunity to
play sports, etc.
What did you like about the BE program?
I liked the electrical engineering emphasis, since it seemed like most other
programs at other colleges emphasized mechanical engineering. I also liked
the small class size, learning about documentation for FDA requirements, and
the internship during the senior year.
What did you like about the student activities and student life at MSOE?
I really enjoyed playing sports at MSOE. I made a lot of really great friends, and
I ended up getting to know a lot more people on campus through playing both
volleyball and basketball. I also had a lot of fun with the homecoming and
St. Pat's activities, especially being a member of a sorority. There always were a lot of fun activities going on in the dorms, too.
Now that you have graduated and are in the workforce, are
you happy with the education that you received in the BE program at MSOE?
Yes, I have been happy with the education I received. The knowledge I gained on the
cardiovascular area, and especially my involvement with the perfusion program have
been extremely valuable for my current position. The very first class we took, the
introduction to BE, where a strong emphasis was placed on documentation, has also
been very helpful while working in the medical industry. I have been much better
prepared for audits by the FDA due to my educational background.
| For information about MSOE's B.S. in Biomedical Engineering program, contact interim program director Dr. Charles Tritt at (414) 277-7421. |