Bryan Pinder Email & Phone Number

Greater Syracuse-Auburn Area

Syracuse, New York Area

United States

- Inform business product development teams, including new product development and sustaining projects, on required medical device performance and safety standards. - Drive safety agency testing planning and execution.- Create and maintain product summary technical documentation (STED files) to support product registration.- Develop market clearance applications and registrations, both in the USA and global markets.

Skaneateles Falls, Ny

-Ensure that a varied medical device catalog complies with ISO 14971. Work with design teams throughout the device life-cycle, from prototoype to post-market, to generate complete risk management files for inclusion into DHFs.- Brief executive leadership on the safety profiles of new devices.- Generate Health Hazard Evaluations (HHEs) for potential field actions.- Help assess complaints for reportability.- Software and hardware failure assessments using FMEAs and fault trees.

White Oak, Maryland

Responsible for analyzing and documenting the safety and efficacy of orthopedic implants in a variety of applications prior to US market release. Provide guidance to industry on device-related mechanical testing, clinical trial design, animal study design, biocompatibility issues, and sterilization concerns. Brief senior-level management on pressing regulatory issues and high-profile/controversial devices.- Coordinated and wrote over 200 orthopedic device reviews ahead of deadline - Organized and lead multi-disciplinary teams to evaluate novel devices and clinical study protocols- Developed guidance documentation for staff and industry on regulatory SOPs and review practices- Developed regulatory and technical expertise on foot/ankle arthroplasty and fracture fixation - Achieved a GS-13 full time employee promotional level

Master Of Engineering - Meng, Bioengineering And Biomedical Engineering

Bachelor Of Science - Bs, Bioengineering And Biomedical Engineering