Director, R&D Engineering – Transcatheter Mitral and Tricuspid Therapies

Edwards Lifesciences - Irvine, CA 92606

Posted a month ago

Director, R&D Engineering – Transcatheter Mitral and Tricuspid Therapies-020929

This is an exciting opportunity for an exceptional engineering professional with significant experience to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.
The Director of R&D Engineering - TMTT is responsible for leading R&D activities including all aspects of implant testing for transcatheter mitral valve replacement devices, (i.e. management of test labs, development of boundary conditions, development of new test fixtures, and response to regulatory agencies) and supporting next generation product development activities. This leader will be responsible for partnering with cross-functional teams, colleagues in other Edwards business units as well as communication with outside regulatory agencies and physician partners. A strong candidate will have comprehensive knowledge and understanding of FDA and ISO guidance for structural heart implants, a strong understanding of test method development and strong project management skills.

Responsibilities include:
  • Plan, staff and supervise a R&D implant test organization which is expected to test sequential generations of the transcatheter mitral valve replacement technologies.
  • Lead development of new test fixtures and test methods to address design iterations and changes in boundary conditions.
  • Manage and drive timelines for feasibility testing activities, design verification testing, and commercial release testing.
  • Primary point of contact for response to regulatory submissions and response to agency questions related to implant testing.
  • Manage budget spending for labs, CAPEX equipment and OPEX spending.
  • Support product development efforts in the design and iteration of new implants, and components for transcatheter mitral valve replacement.
  • Demonstrates focus on staff development, ethics and motivation through appropriate assignment of opportunities and training activities as needed to support achievement of both professional development goals as well as business goals. Actively engage in development of staff performance management objectives (PMOs), ensuring deliverables are met on time and within budgeted cost parameters.


Education, Experience and Training:
  • BS or BA degree in related scientific and/or engineering field is required, Master's or Doctorate degree in mechanical engineering is preferred.
  • A minimum of ten (10) years of demonstrated success providing leadership in medical device organizations.
  • Strong technical knowledge and execution skills with a demonstrated ability to design and test product concepts that are clinically usable.
  • Direct prior experience with heart valve therapy products and catheter based interventional products inclusive of design programming skills, as well as test protocol experience.
  • Experience working with key opinion leaders in the field to identify market requirements, industry and regulatory partners.
  • Strong interpersonal skills and people management skills. High emotional intelligence.
  • Displays broad perspective and effective judgment, demonstrates well-reasoned problem solving and decision-making.
  • Builds a shared vision; inspires others to action; sets clear direction; establishes plans consistent with that direction.
  • Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer and patient needs.
  • Ability to work in a matrix organization and lead cross functional teams.

The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment.


Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.



For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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