Lisa Tan possesses extensive experience in biomedical engineering and human factors within regulatory settings. At the Office of Device Evaluation, CDRH, FDA, from October 2008 to February 2011, Lisa served as a Biomedical Engineer and Lead Scientific and Regulatory Reviewer, where responsibilities included leading reviews of medical device submissions and improving review processes. Currently, Lisa holds the position of Director of Human Factors at Kymanox since October 2020, focusing on developing human factors strategies and managing usability engineering programs, particularly for combination products. Previous roles included serving as a Human Factors Specialist and Associate Director for Human Factors in the Division of Medication Error Prevention and Analysis, FDA, with a focus on evaluating human factors validation methods and overseeing human factors teams. Educational qualifications include a Bachelor's degree in Biomedical/Medical Engineering from The George Washington University, a Graduate Certificate in Global Health from the University of Maryland, and a Master's degree in Systems Engineering from The Johns Hopkins University.
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