Joel Difonzo

About Joel Difonzo

Efficient and highly motivated leader with a diverse background in engineering and engineering management.Specialties: • Medical Device Quality / Manufacturing / Product Development• Six Sigma Black Belt• Process Validation • FDA Regulation • Design Verification and Validation • FDA Enforcement Policy• Plastic Injection Molding • Risk Management• 21 CFR Part 11 • Customer and Supplier Management• Tooling / Fixture Development

Experience

1. Vice President, Quality, Transcatheter Heart Valves

   Edwards Lifesciences

   Jul 2025 — Present · Irvine, CA, US

   Transcatheter Heart Valve Division - Aortic, Mitral, Pulmonary Valve ReplacementResponsibilities: • Management, development and technical support of multiple Quality Engineering teams devoted to next generation transcatheter heart valve implants, delivery systems and accessories.• Quality Rep / Integration lead of a new acquisitions / technologies.Team responsibilities:• Commercialization, evolutionary development activities, and early stage innovations slated for feasibility or early human use.• Laboratory management responsibilities with a specialized team focused on development of advanced quality inspections / initiatives.• Leading or piloting next generation product development initiatives

Education

• Kettering University

  Bachelors, Mechanical Engineering with a Biomedical Concentration

  2003 — 2007

Skills

• Minitab
• 21 Cfr Part 11
• Medical Devices
• Fda
• Manufacturing Engineering
• Failure Mode and Effects Analysis (Fmea)
• Iso 13485
• Lean Manufacturing
• Six Sigma
• Injection Molding
• Spc
• U.s. Food and Drug Administration (Fda)
• Root Cause Analysis
• Quality System
• V&V
• Gd&T
• Customer Management
• Cross-Functional Team Leadership
• Supply Management
• Design Control
• Risk Assessment
• Fmea
• Validation
• Product Development