Thomas Graf Email & Phone Number

Lafayette, Colorado, United States

Louisville, Colorado, United States

Bloomington, Indiana Area

• Project lead for DHF remediation efforts for ureteral stents and stent sets.• Reviewed post-market surveillance data to establish a risk profile for devices.• Established design control and risk documentation, including risk management plans, clinical effect analyses, user needs, design outputs, design verifications, hazard analyses, and FMEAsInvestigated product nonconformance, including development of a risk management plan, clinical effects analysis, hazard analysis, FMEA, and risk management report.• Selected to alpha test new software meant to provide a systems engineering approach to medical device design controls

White Oak, Md

• Carried a research project at US Food and Drug Administration through the Center for Disruptive Musculoskeletal Innovations (CDMI) and the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI).• Studied 510(k) submission data to categorize industry methods for carrying out performance testing via finite element analysis (FEA).• Helped lay a foundation for the future best practices methodology for FEA of spinal fusion cages using expert input from industry, regulatory, and academia.

Master’S Degree, Mechanical Engineering

Bachelor’S Degree, Bioengineering And Biomedical Engineering, 3.60 Gpa - Graduated With Distinction

Activities and Societies: Varsity Swim Team (NEWMAC Academic All-Conference), Deans List (2012-2015), Lacrosse Club

Bioengineering And Biomedical Engineering, 3.64 Gpa

Activities and Societies: Dean's List Club Swim TeamTransferred