Proficient in ISO13485 Quality Management Systems, ISO14971 Risk Management, FDA 21 CFR Part 820 Quality System Regulation. Managed engineers (R&D and Quality), technicians, hourly employees, and contractors. Selected as R&D Product Engineering lead for multiple EP catheters and oversaw development through all design phases. Designed and built medical devices and tooling. Exposed to broad medical device background including AAA, EP Catheters, OB/GYN products, Catheter Based Radiation Therapy Devices, Cardiology Catheters, and Orthopedic implants. Functioned as: Quality Manager, Quality Engineer, R&D engineer, Project Leader, and Manufacturing Engineer. Led design, process, and test method validation efforts. Well versed in drawing interpretation and inspection techniques. Experienced in Solid Works, ProE and AutoCAD. Operated machine tools. Programmed CNC Swiss Lathes. Invented & submitted patentable ideas (inventor on 23 US & 13 International patents). Ability to find problems, develop solutions, implement effective changes, analyze impacts, and react accordingly.