Dr. Jay Vincelli, PhD, PE, is a licensed Professional Engineer (PE) in mechanical engineering and PhD-level biomedical engineer specializing in the forensic analysis of medical devices for product liability and patent litigation. His work is built on a strong educational foundation, including a BSc in Materials Engineering, and an MSc and PhD focused on Biomedical Engineering. This unique, cross-disciplinary background allows him to provide clear, credible, and defensible insights into complex device failures.

Dr. Vincelli’s expertise is highlighted by his deep experience in litigation support, where he has provided engineering analysis for approximately 100 cases involving failed medical devices. His case experience is extensive, covering orthopedic implants, transvaginal mesh, cardiac devices, forced-air warming systems, and more. His work at Dartmouth College involved the detailed failure analysis of over 500 metal-on-metal hip implants, including wear measurements and pore size measurements on the bone ingrowth surface. In addition to his litigation work, he has direct industry experience supporting FDA regulatory submissions, including performing degradation experiments for the OrthoSpace rotator cuff balloon’s FDA submission and providing guidance to CREmedical for the FDA clearance of their advanced EEG amplifier and electrode devices. His practical experience also includes the design and manufacturing of a hip explant surgical tool.

His qualifications are further strengthened by comprehensive training and experience in industry-standard quality systems. This includes developing an ISO 17025-compliant quality manual, and receiving training in ISO 10993 for the Biological Evaluation of Medical Devices and as an ISO 9001 lead auditor.

While his primary focus is biomedical engineering, Dr. Vincelli also has significant experience in other industries. His background includes automotive failure analysis and product launches, as well as numerous forensic investigations of aviation components for the U.S. Naval Air Warfare Center in Cherry Point, NC, where he also performed welding analysis and certification of the Navy’s welders. Additionally, he is a published author on the use of photogrammetry for underwater analysis and forensic science.