Jim Isaacson

Jim Isaacson
Sr. Director of Quality and Regulatory Affairs

Jim Isaacson has over 32 years of experience in the Medical Device industry, having worked on a wide variety of technologies including Dialysis, Electrosurgical instruments, non-invasive drug delivery, Oxygenators, and X-Ray. Jim spent the first 25 years of his career in R&D prior to moving to Quality where he has created new Design Assurance departments and their associated QMS processes such as Design Controls and Risk Management at Fresenius Medical Care and JUUL Labs. He has led teams in authoring various Quality System elements that have experienced over a dozen successful FDA inspections.

His work experiences include extensive project and personnel management, Design Controls, Risk Management, Process Validation, DOE, statistics and life cycle product management. He uses a market-driven approach resulting in strong IP (co-inventor of 27 patents), consistent with a Quality approach for doing it right the first time. He is a mechanical engineer by training with an MSME from Massachusetts Institute of Technology, and a BSME from the University of Michigan.