Hands-on medical device engineering professional with 10 years of experience developing Class III and II medical devices. Product expertise includes cardiovascular devices (coronary and peripheral stents, PTCA balloons, abdominal aortic aneurysm stent-grafts) and insulin infusion pump systems. Expert in FDA and EU requirements for medical products commercialization. Areas of expertise: - Vascular devices development. - Design Control. - CAD (SolidWorks). - Design /Process Excellence (Six Sigma). - Test Method Development and Validation. - Design Verification and Design / Process Validation. - FDA Guidance for Non-Clinical Tests of Intravascular Stents. - VICTOR M Manufacturing operations (process development, GMP, regulatory compliance).