My career is marked by a distinguished record of scientific achievements, multifluency, & a demonstrated commitment to effective leadership through collaborations. I excel at process innovation through coalition-building, adeptly leading change and guiding people with boundless energy and enthusiasm. My strengths lie in engaging diverse stakeholders, critical thinking, creativity, and organizational skills which I have applied to help modernize the FDA, always with an eye toward improved quality of care delivered to patients. Now with more than 20 years of experience, I’ve expanded on my formal training in mechanical engineering and numerical modeling to become instrumental in the innovation of medical products through advanced regulatory science. I've created initiatives, led interdisciplinary teams, developed industry standards, and engaged diverse stakeholders as I’ve ascended into the Office of the Chief Scientist (OCS), all while focusing on regulatory credibility and industry education.Before joining OCS, I advanced the role of computer modeling and simulation in medical device design and product evaluation during her tenure at FDA. Lauding my work ethic, in 2016 the FDA OCS entrusted me with forming and leading an agency-wide working group on modeling and simulation, whose first workshop attracted hundreds of FDA participants. I also headed the drafting of FDA’s breakthrough guidance for modeling: Reporting of Computational Modeling studies in Medical Device Submissions, attracting international recognition, and co-authored the final FDA guidance on Credibility Assessment. Outside the Agency, I led the development of pathways for enhancing modeling credibility and acceptance. For instance, I was selected by her peers to lead a 3-year effort in developing a verification and validation standard for ASME, which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices. The FDA recognized this standard for support medical device evaluation. Because of these efforts, I was selected as the 2019 Federal Engineer of the Year for FDA. I also served as Chair of the ASME Committee on Verification & Validation (V&V) of Computational Modeling, where I lead the development of a methods to assess the credibility of computational models. I helped lead the ASME V&V40 standard, published in 2018, culminating 6 years of work with 40+ industry partners. I worked with CDRH to implement this strategy into the review of premarket submissions that harness CM&S, now being translated to AI credibility assessment.