Edwards Lifesciences Sr. Manager, R&D Engineering - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Helping patients is our life’s work, and your contributions directly impact our ability to transform patient care around the world.” – Michael A. Mussallem, Chairman and CEO
This is an exciting opportunity for an exceptional engineering professional 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.
This Irvine based Sr. Manager of Research and Development is responsible for leading a fast-paced program in the early stages of development. The Sr. Manager will be a key contributor to the design and program leadership of delivery systems for transcatheter mitral valve replacement (TMVR). A strong candidate will be a hands-on leader with sound technical knowledge, strong leadership skills, and the ability to lead and develop a highly driven and dynamic technical team. He or she will lead product design and development of the delivery system products and be accountable for achieving new and generational improvements of this transcatheter mitral replacement therapy. This position will report into the Director of Delivery System R&D Engineering for Transcatheter Mitral and Tricuspid Valve Replacement.
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 that offers potential for growth and professional advancement for the right candidate.
Lead the design, development and testing of complex interventional catheters for delivery of implantable devices.
Manage and drive timelines for feasibility testing activities, design verification testing, and commercial release testing.
Coordinating with and driving cross-functional support teams to achieve team goals.
Support product development efforts in the design and iteration of new delivery systems, and components for transcatheter mitral valve replacement technologies.
Interface with Manufacturing, Clinical Affairs, Quality, Marketing, Vendors and Suppliers to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).
Demonstrates focus on staff development, ethics and motivation through appropriate assignment of opportunities and training activities to support the achievement of both professional development goals and business goals.
Actively engage in development of staff performance management objectives (PMOs), ensuring deliverables are met on time.
The ideal candidate requires a Bachelor's degree in engineering; mechanical or biomedical is preferred and a minimum 12 years of experience in the medical device industry OR a master's degree in engineering with 10 years of medical device experience.
Medical Device experience in new product development with successful design from concept to FIH is required.
Strong interpersonal 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.
Required skills and experience include:
Skills in mechanical design and Delivery System catheter design.
Experience in catheter and related manufacturing (extrusions, braiding, molding, laser-cutting and bonding processes).
Experience managing engineering teams and cross-functional relationships.
Clinical and anatomical knowledge with an ability to communicate with collaborating physicians.
Proven ability to apply technical knowledge and judgment to complex engineering problems.
Able to demonstrate strong skills as an innovator, problem solver, and mentor.
Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method
development (in-vitro and in-vivo).
Strong problem solving and root cause analysis skillset and the ability to rapidly iterate and react to clinical device feedback.
Preferred background includes experience in more than one of the following areas: Interventional access devices, rapid product development, and Mechanical component design.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.