Over 25 years of Operations, Manufacturing Engineering and Manufacturing Engineering Management.• Project Management: Led many successful projects and developed team members in multiple disciplines. • Expertise in documentation including validation/proofing protocols, procedure definition, engineering justifications and training.• With over 35 years of experience in medical device manufacturing familiar with the requirements for medical, FDA and ISO 13485 certifications.• Comfortable working in a highly regulated industry. • Extensive Medical Device experience which includes management of manufacturing, manufacturing engineering, product development, quality, maintenance and facilities.• Strong leadership and interpersonal communication skills used to mentor high-potentials, build employee "self-directed" teams, and develop management systems.• Extensive manufacturing and manufacturing engineering experience including all aspects of machining, molding, fabrication, welding/joining, finishing, assembly and processing from raw material to final packaging.• Highly innovative problem solving to find creative solutions for difficult to resolve design, process, quality and procedural issues.• Extensive supply chain experience including JIT manufacturing and all aspects of quality planning for product transfer from current to future manufacturing sites. • Considerable knowledge and experience in the cleaning, passivation and sterile packaging of medical devices.• Training and experience in Lean Manufacturing and Six Sigma principles.