Elaine Soohoo, Ph.D. in a Biomedical Engineer in the Office of Cardiovascular Devices at the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) where she leads reviews for clinical trials, marketing applications, device cybersecurity, and post-market safety signals and recalls. She served as a Scientific Advisory Committee Member for the FDA/Dassault Systèmes Living Heart Project evaluating the feasibility of using data generated by a computational heart model to reduce human burden in clinical trials and has also worked on a number of FDA/CDRH DEI initiatives. Previously, she served as a Policy Analyst in the Food, Health, and Labor Branch of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) in the Executive Office of the President (EOP).
Prior to her work in the government, she was a Clinical Artificial Heart Biomedical Engineer at the University of Pittsburgh Medical Center and Children’s Hospital of Pittsburgh, and a Mirzayan Science and Technology Policy Fellow at the National Academies of Science, Engineering, and Medicine. In a previous life, she worked as a R&D Lab Associate for Walt Disney Imagineering. She received her B.S. in Bioengineering from University of California Berkeley, and her M.S. and Ph.D. in Biomedical Engineering from Carnegie Mellon University where her research focused on the development of computational living heart models to support the development of a novel, non-thromboembolic cardiac assist device inspired by the natural twisting motion of the beating heart.