Michelle Zwernemann

VP of Regulatory Affairs & Quality Assurance

Ms. Zwernemann, MSE, is a biomedical engineer with over 10 years of experience in medical device development and commercialization. As a hands-on engineer at Synthes, Inc., she contributed to the design, testing, and launch of several orthopedic implants with roles ranging throughout the complete product life-cycle, including needs identification, manufacturing and post market surveillance in both the US and international markets. While leading product development at an upper limb prosthetics company, Michelle was responsible for project management, regulatory strategy, and design transfer while also implementing a full QMS and launching an embedded platform with multiple product offerings for advanced control of multi-articulated prosthetic hands. She also regularly lectures on design controls and risk management at Johns Hopkins University and holds an appointment as a lecturer with JHU Engineering for Professionals. Michelle holds a BS and MSE from the Biomedical Engineering Department at JHU.