Career Story: Manufacturing Engineer At A Medical Device Maker

Manufacturing Engineer At A Medical Device Maker

Job Title: Manufacturing Engineer

Type of Company: My company makes medical devices related to open-heart surgery.

Education: BS, Engineering, Cornell •• MS, Mechanical Engineering, Cornell

Previous Experience: I was a mechanical design engineer at three companies in the New York metropolitan area. After moving to California, I designed printers for two companies, chemistry lab robots at a third and at my last job I maintained production equipment at a medical device company.

Job Tasks: As a manufacturing and production engineer for a medical device company, my main responsibility is to prevent interruptions to the production process. The devices we make are assembled in a clean-room; the assemblers and I wear full "gowns" and our bodies are completely encased (except around the eyes and there we wear safety glasses).

I maintain the machines we use and troubleshoot them when there is an assembly problem or difficulty with the materials we receive from outside suppliers. At any time, the production supervisor can present me with a problem relating to one of the above areas. My job is to figure out the cause of the problem and fix it as quickly as possible, so that work can resume. The kind of costly, unwanted down-time ranges from a few minutes to a few hours. I need to keep a supply of spare parts for the machines. When I was hired, there was nothing written on how to troubleshoot or maintain the equipment, which was custom-built over 10 years ago, and all the employees involved were gone. I was a detective much of the time and typed hundreds of pages in the computer to document what I found, to help others once I have moved on.

Other parts of my job are to write up problems on forms, write Change Orders to correct drawings or procedures, and qualify new equipment.

Best and Worst Parts of the Job: The best parts are the challenge and variety of working on many different pieces of equipment. I enjoy the "detective work" of figuring out how each machine works and writing up clear descriptions for future users. Wearing the gown ("bunny suit") is OK most of the time, as I'm partial to wearing uniforms. It got uncomfortably hot when I had to move machines or tables, or climb ladders. It forced me to be organized so I could bring all the items (tools, manuals, etc) into the cleanroom in one trip, instead of gowning and ungowning several times to go get another item. (The cleanroom is supposed to be free of anything except the product being made).

The worst part of my job is being "on-call" evenings and weekends and knowing I'd have to show up at 6 AM on a Sunday or 10 PM if they called with a problem.

Job Tips: The job of manufacturing engineer at a medical device company requires that you really enjoy working in a bunny suit, enjoy troubleshooting complex equipment and enjoy technical writing and doing "paperwork" (some of which is actually still on paper). It also helps if you enjoy doing a variety of activities. Medical device companies are regulated by the US Food & Drug Administration (FDA), so there are very strict rules (and hundreds of written procedures) which govern everything you do. To like this job and be successful at it, you must be self-disciplined and enjoy -- not simply tolerate -- the discipline imposed by the company.

Additional Thoughts: As someone who started working before personal computers were invented, I've had to struggle constantly to learn to use a variety of programs that are much more complicated than Microsoft Word (Excel, computer design & drawing programs, etc). I have also been surprised at how much FDA rules affect everything we do and how we do it.

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