Da-Yu Chang

About Da-Yu Chang

Medical device professional with 20+ years of experience in new product development (50+ patents), leadership, and launch/commercialization in developed (US, EU, Japan) and emerging markets (China, India); Passionate about making meaningful impact on patients’ quality of life.Specialties: Medical Device, New Product Development, Cross-Functional Team Management and Leadership, Design Control, Management Consulting

Experience

1. Sr Director, Engineering, Surgical Structural Heart R & d

   Edwards Lifesciences

   Feb 2013 — Present · Orange County, CA, US

   Heavyweight Team Leader – MITRIS RESILIA Mitral Valve, INSIPRIS RESILIA Aortic Valve (2019/2020 Prix Galien Award Nominee)- Led & managed cross-functional team for next generation surgical aortic & mitral valves. Directed product development efforts from ideation to commercialization (Concurrent product launches in both US & international markets). Drove team to meet objectives on safety, patient-benefits, performance, time-to-market, & COGS reduction. Developed milestone, project risk mitigation, resource allocation, concept & design selections. Reviewed project progress monthly with business unit leadership team- Launched products generate ~50% of revenue for business unit. Responsible for managing cost center with annual budget >$2M. Consistently operated to plan with <5% variance- Oversaw and provided guidance on CAD design, design control, risk management, usability, biocompatibility & chemical characterization, chronic pre-clinical animal study, and process validation deliverables for regulatory submission (PMDA, PMA, EU MDR, & NMPA). Provided technical expertise to help resolve deficiency questions during review/approval process. Presented evidence to & interacted with regulatory auditors & inspectors during pre-submission consultation meetings & pre-approval site inspection- Multiple patents issued (additional patents pending)- R&D Lead – Product Introduction for China- Support all surgical valve products regulatory approval & recertification in China. Review & develop testing specification. Interact as SME with national/provincial test labs to support type testing. Coordinate with international RA to support submissions, engagements, & on-site inspections with NMPA/CFDI. Interact with & present to NMPA reviewers on valve hydrodynamic testing, fatigue testing, new product designs/features & test methods- Participate in monthly IP review for competitive analysis & IP protection

Education

• UC Irvine

  BS, Mechanical Engineering

  1992 — 1996

• University of California, Irvine - The Paul Merage School of Business

  MBA, Business Administration

  2007 — 2010

• UC Irvine

  MS, Mechanical Engineering

  1996 — 1998

Skills

• Research and Development (R&D)
• Injection Molding
• Product Development
• Medical Devices
• Root Cause Analysis
• Cardiovascular
• Launching of New Products
• Testing
• Management Consulting
• Sop
• Fda
• Pro/Engineer
• Cross-Functional Team Leadership
• Pro Engineer
• New Product Ideation
• U.s. Food and Drug Administration (Fda)
• R&D
• Iso 13485
• Commercialization
• Six Sigma
• Product Launch
• Quality System
• V&V
• Process Simulation
• Design of Experiments
• Manufacturing
• Biomedical Engineering
• Design Control
• Medical Device Product Development
• Surgery
• Solidworks
• Validation