Director, R&D Engineering

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

Role Summary:

• You will lead a group of teams with focus on valve replacement for the mitral and tricuspid valves, from concept phase till early human use trials/transfer to manufacturing. The team goal is to design a heart valve dedicated to be delivered to the mitral or tricuspid valves via transcatheter approach.
• You will lead the project planning (timeline and budget), product needs and design requirements, conceptual design and analyses, detailed design and testing efforts to mature concepts and bring products to design transfer stage. This is a unique position which allows us to influence future designs and bring innovation into Edwards portfolio.
  
  

• Manage 2-3 team leaders including R&D engineers and technicians (10-14 employees)
• Lead design projects from early-stage feasibility till design transfer.
• Perform R&D feasibility testing and design verification testing
• Collaborate with cross functional teams (pilot manufacturing, testing, clinical development, quality).
• Plan, manage and execute projects in aspects of milestones, timelines and budget.
• Lead proof of concept development work including animal trials, in-vitro testing and supporting analyses.
• Develop and mentor the team leads (valve and delivery system).
• Manage close relations with global stakeholders and physicians (Irvine California).
• Develop and retain talent to become the valve team of choice.
  
  

• B.Sc. in Mechanical/Bio-Medical Engineering
• At least 10 years of experience in R&D. Medical device background is a must.
• Analytical thinking and exceptional planning abilities.
• At least 7 years of managerial experience of R&D teams (leading managers)
• Proven track record of delivering a product from concept to realization – strong advantage.
• Corporate experience – advantage.
  
  

• FEA knowledge – strong advantage
• Agile project management
• Medical device design and development process expertise with knowledge in materials
• Strong engineering skills (fluid mechanics, finite elements and mechanics) and knowledge in relevant software (e.g. Solidworks, Abaqus)
• Testing design and execution with strong statistical knowledge and use of statistical SW (Minitab)
• Regulatory and quality systems knowledge (e.g. ISO5840, ISO5940)
• Strong team building capabilities with mentorship skills
• Critical thinking and problem-solving approach