Maiquyen N.

Biomedical Engineer @FDA

Silver Spring, MD, US

Lead reviewer and durability reviewer on the Vascular and Endovascular Devices Team in the Office of Cardiovascular Devices (CDRH) reviewing PMA, 510k, De Novo, HDE, and IDE submissions.Managed teams of 3-14 highly trained team members, including physicians and engineers, to complete technical and regulatory reviews. Evaluated mechanical engineering data to determine whether devices met technical standards and had acceptable benefit/risk profiles.Represented FDA as a panelist and presented FDA position on medical device therapiesto academic and clinical communities (Greenberg Stent Summit).

The University of Texas at Austin

Bachelor’s Degree

Carnegie Mellon University

Master's degree