AAMI News September 2017

One on One: Mike Ziemelis

Mike Ziemelis
Mike Ziemelis is a senior engineering manager for Stryker’s Integration Management Office and a faculty member for AAMI University’s course Design Control Requirements & Industry Practice.

Why did you choose a career in the medical device industry?

I started in the medical device industry right out of school. After I got my undergraduate degree in electrical engineering, I had a chance to interview at a few different companies, one of which was Stryker. I really enjoyed the people who were there when I went through the interview process, but I also really enjoyed the mission and the fact that Stryker makes devices that help improve people’s lives. That got me really excited about working for the medical device industry, and I haven’t looked back.

What do you do in your current position?

Specifically what I’m focused on is conducting due diligence on companies and products we might want to acquire. I look at the quality and design of the product and the quality system overall to see if it would be a good fit for Stryker. After that, if we decide to go forward and sign a deal with them, we do what is called integration to bring them into Stryker’s systems and potentially make small changes. So basically, I work to figure out what could potentially bite us, and then we conduct integration to fix the identified gaps.

What is the best part of your job?

The best part of my job is the opportunity to visit other companies, not just to see the great products and services that they are providing, but also to learn about the different ways they have chosen to implement the Food and Drug Administration’s quality system requirements.

Why did you want to become an AAMI faculty member?

There were two reasons. The first was to be able to take my knowledge and help teach other people about the various regulatory requirements. The second reason was to learn from other people from various companies.

Why did you decide to teach the design control requirements course?

My uncle, who was a farmer, once told me: “You either are making things, or you are repairing things.” He made life very simple. In my career, I’ve gravitated toward new product development because I enjoy making things. That’s also why I have really enjoyed teaching design controls. I get to teach people how to pair innovation with regulatory requirements so when new products are developed, they can be safe and effective. We can make products that help save people’s lives.

You taught your first AAMI University course in May. What was that like?

I loved it. I have had experience training people on design controls, risk management, and other topics at Stryker throughout the various roles that I have had, but it was an exciting experience to be able to teach and learn from other people outside of Stryker.

What type of student were you?

I definitely was excited to learn about math and science, but if I was in my English class, I did the bare minimum required to get a ‘B’. You know, looking back, I wish I would have spent a little bit more time on things such as philosophy or English, but now I am finding an interest in those topics and exploring them in my spare time.

What does it take to be a good instructor?

A passion to learn and a passion to mentor, teach, and develop people are both critical aspects of being an instructor. Not being afraid to stand up and make a mistake is also important. When you are doing a presentation, it is not going to be perfect, so you have to be willing to get up there and tell people what you know, and if you do make a mistake, own up to it and move on. Those are probably the most important aspects of being an instructor.

What advice would you give to someone who was interested in becoming an AAMI faculty member?

Make sure you sign up to teach a subject you are passionate about. If you are not passionate about the topic, it is very apparent to the students in the class, and they don’t necessarily feel the class is as engaging.

What do you like to do outside of work?

I love spending time with my family, especially in the summer when we are going to the beach and spending as much time outdoors as possible. I also like doing triathlons, so I am training for those by running, biking, and swimming. I haven’t done any of the Ironman ones, only Olympic-length triathlons.

What is something people might be surprised to learn about you?

I was actually thinking about being a performance major for trombone. I was pretty good at playing trombone in high school, and when I was looking at where I wanted to go to college, I had the opportunity to audition at a couple of places and actually got some scholarships. But then I thought about it and decided I didn’t want music to be something I was using to pay the bills. I wanted to have it be something that was fun for me, so I decided to go into engineering instead because I liked that too.