Lisa Simone

Lisa Simone is a senior health scientist and biomedical engineer within CDRH’s Office of Strategic Partnerships and Technology Innovation. She is currently an incident response lead for CDRH’s Ethylene Oxide Tiger Team, a cross-functional group that provides strategic planning and response to help ensure continued access to sterilize medical devices. Dr. Simone has led similar emergency response efforts, including for shortages associated with the COVID public health emergency, and previously for cybersecurity and other safety signals. Dr. Simone has provided leadership in software and instrumentation premarket review, standards development, recall analysis and guidance development in both CDRH and the Center for Biologics Evaluation and Research (CBER) before coming to FDA from industry as an R&D engineer and research professor. She earned her PhD in Biomedical Engineering from Rutgers University and an MS in the Management of Technology from the Wharton School and University of Pennsylvania.