Jenny K.
- Role
- Biomedical Engineer Lead Reviewer at FDA
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Jenny K.
Biomedical engineer with background in tissue engineering and 3D Printing. Lead Reviewer…
Experience
Biomedical Engineer Lead Reviewer
Oct 2019 — Present
Lead Reviewer for the Coronary Interventional Devices Team (CIDT). Biocompatibility and engineering consulting reviewer for teams across the Office of Cardiovascular Devices (OHT2). Serve as a lead reviewer for cardiovascular device and combination product pre- and post-market submissions (e.g. 510(k), IDE, Q-submission, PMA, recalls, post-approval studies), including coronary drug-eluting stents, delivery systems, and robotic assisted systems. Consult on a variety of products across the Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices, including ablation catheters, cardiac envelops, and AED electrode pads.
Education
University of Maryland
Bachelor's degree
2015 — 2019
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