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Santa Ana, California
Engineering Manager, Post-Market Product Assurance
Kara Bliley Cross, Ph.D., has worked for Medtronic for the last seven years — first in Colorado and now in Orange County, California. With an undergraduate degree in biomedical engineering and a graduate degree in biomedical engineering from Mayo Clinic Graduate School of Biomedical Sciences, she thought she’d work in medical device design and development. Her career path led her toward product quality assurance for structural heart valve therapies, and she loves her role at a leading device manufacturer.
After my junior year in college I completed Mayo’s SURF (summer undergraduate research fellowship). That summer I learned about Mayo’s graduate program and applied right away to pursue a Ph.D. in biomedical engineering. I liked the professional environment at Mayo and felt its unique program would afford me independence and collaboration with physicians.
For my Ph.D., I developed a wearable device to measure human motion, and learned what was required to get a product to market. Before that I had little knowledge of the FDA requirements, regulatory submissions and testing involved for commercializing medical devices.
I always knew I wanted to go into industry versus academia. With my engineering background, the tangible world of devices was more appealing than pharmaceuticals. Working for a device company seemed like a solid career with a lot of innovation.
After completing my Ph.D., I worked for a Twin Cities company as a regulatory engineer on blood glucose monitors. I also always wanted to work for Medtronic — the leader in medical devices — which I started doing in 2010. The rapid changes in technology fascinate me. I see how it will drive where medicine is going. Medtronic’s CEO recently discussed his vision of the company being more than just a device company and more of a health care solutions company.
I didn’t imagine I’d be doing exactly what I do. I thought I’d be more involved in design and development of medical devices. Instead, I’m involved in the quality aspects of the business — risk management, safety and hazards information, and demonstrating effectiveness.
I lead a team of engineers who monitor performance of structural heart valve therapies to ensure the products are safe and effective for patients. With patient feedback, we continually improve the products. Previously I worked in the neurosurgery business for Medtronic — also in post-market quality. I am seeking to keep learning new processes and new products.
I work hard, the job is challenging and the industry is very competitive. I stretch myself every day and like what I do. I also feel supported. My company also really values personal development, taking time off, and having flexibility for work and life. A couple of years ago I completed my MBA while working full time, with financial support from Medtronic.
Not a lot of women are doing what I do, but that’s changing. My manager is a woman, and I have a team of eight engineers and technicians — six of whom are women. In my short history in this business, that’s unusual, but it’s one of the cool things about Medtronic. Our CEO has a goal to increase the number of women across the organization, including engineers and senior leadership.
Most people in this business who have Ph.D.s are in R&D or clinical research. I haven’t met many who work in the quality function although our VP of Global Quality is a woman with a Ph.D. While what I do would not require a Ph.D., my Ph.D. training strongly prepared me in terms of critical thinking.
Getting a Ph.D. isn’t going to automatically put you ahead of your peers who don’t have that degree, but when you do the work you’ll stand out because of your critical-thinking skills. I also have found that individuals who have completed Ph.D. programs tend to have more resilience and persistence. You’ll be a much stronger employee and asset to the business. To get through a Ph.D. program you have to really want it. Having the degree isn’t what defines you. Who you became in the process of getting the degree is what matters. When I finished my PhD, I needed a break. I decided to take some time to figure out what I wanted to do next. Now that I’m farther past that time, my confidence is a lot higher than when I started the program. When you’re a Ph.D. student, you own everything about your project. That gave me an opportunity to be a leader.
I’ve been in California for not quite a year, so I’m busy exploring the state and making new friends. There is so much to see and do! I spend a lot of time outdoors by the ocean because the weather is always beautiful. After my Ph.D. program I trained to be a yoga instructor, so I practice yoga regularly. It keeps me balanced, with the stresses of work and life. I’m also active in different networking organizations. I try to find opportunities to give back to the community and mentor others earlier in their careers.
See past New Chapter stories here.