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Jim Gustafson


After my MS in Biology at UCI in 1978, I began my career in the medical device industry. I worked for several Orange County medical device companies, first in clinical science — designing and managing the human trials of new devices required by FDA to prove that the device is safe and effective. In 1989 I moved to Minneapolis to continue my career at two additional employers. My final title was Sr. Vice President, Clinical Science and Regulatory Affairs. But during the years I had been responsible for R&D, Engineering, Quality, Manufacturing, and Logistics, and had been General Manager for Minneapolis Operations. My proudest accomplishment was participating in the development and commercialization of a life-saving interventional cardiovascular device, and growing the company from 30 employees, 0 sales, and 0 profits to 250 employees, $80M annual sales, and high profitability. We sold the company in 2008 for $361M. I stayed with the acquiring company until 2012, when I moved my family back to Irvine CA and started consulting part-time. In 2018 I fully retired, but I remain active in the medical device community.

Personal Interests

I am active in my church, teaching and leading adult Bible studies. I also developed and now direct an English as Second Language (ESL) training center at my church. I network actively with medical device professionals in Orange County, volunteer at OCTANe LaunchPad to help start-up medical device companies, and am a volunteer docent at the Laguna Beach Tide Pools via the Laguna Ocean Foundation. I sing bass with a local master chorale that performs sacred choral music. I have served on the board of several non-profit organizations. I enjoy biking, reading, traveling, and the lively arts.

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