Presenter

Carolyn Hartzell is a Principal Engineer and Managing Consultant at Evolution Engineering, specializing in complex high-risk medical device projects. With a background in Electrical Engineering (BS) and Human Factors Engineering (MS), Carolyn collaborates effectively with diverse engineering teams. She has held in-house Human Factors Engineering roles at Beckman Coulter and Zoll before transitioning to consulting. At Evolution, Carolyn leads end-to-end project management, including developing HF plans, conducting task analysis, developing, and maintaining URRA, and conducting formative and summative studies. She works closely with cross-functional client teams on residual risk analysis and HF/UE Summary reports crucial for FDA submissions.