Nathan Weidenhamer

About Nathan Weidenhamer

With over a decade of experience in the medical device industry, my core competencies lie in regulatory affairs, medical device innovation, and leading cross-functional teams. At FDA, my mission is to ensure the safety and efficacy of vascular and endovascular devices, in alignment with the agency\'s commitment to public health.In my most recent role as a Lead Reviewer at the FDA, I spearhead the evaluation of scientific data in regulatory submissions. My responsibilities included organizing teams of experts, providing technical advice, and preparing comprehensive review documents. Through rigorous analysis and clear communication, I contribute to the FDA\'s crucial decisions on medical device regulatory submissions.Device expertise: tissue engineered medical products, vascular grafts, aortic endografts, hemodialysis access, interventional catheters, surgical and transcatheter heart valves, venous valves

Experience

1. Biomedical Engineer

   FDA

   Mar 2023 — Present

   Lead and Engineering ReviewerVascular and Endovascular Devices TeamDHT2B: Division of Circulatory Support, Structural and Vascular DevicesOHT2: Office of Cardiovascular DevicesCDRH: Center for Devices and Radiological HealthLead Reviewer Responsibilities-Organize and lead a team of subject matter experts to review scientific data in medical device regulatory submissions (IDE, PMA, 510(k), De Novo)-Provide technical and regulatory advice on applicable consensus standards and FDA guidance documents-Prepare written technical documents summarizing technical reviews-Prepare and present recommendations to senior level managementConsultant Responsibilities-Review delivery system and implant non-durability test protocols, data, methodologies, and reports provided in support of a marketing application for cardiovascular devices-Review quality systems documentation in support of a marketing applications for cardiovascular devices-Review trends in medical device reports (MDRs) to identify post-market safety signals or device quality issues

Education

• University of Minnesota

  PhD, Biomedical Engineering

  2008 — 2013

• Penn State University

  BS, Bioengineering

  2002 — 2006

Skills

• Research
• Life Sciences
• Lifesciences
• Histology
• Immunofluorescence
• Commercialization
• Cell Culture
• Immunostaining
• Biomaterials
• Fluorescence Microscopy
• Immunohistochemistry
• Characterization
• Tissue Engineering
• Design of Experiments
• Biotechnology
• Stem Cells
• Biomedical Engineering
• Regenerative Medicine
• Tissue Culture
• Graphpad Prism
• Matlab
• Medical Devices
• Capa
• Gel Electrophoresis
• Rna Isolation
• Product Development
• Image Processing
• R&D
• Bioreactors
• Confocal Microscopy
• Mechanical Testing
• Validation
• Imagej
• Cell Biology