Edwards Lifesciences Manager, R&D Engineering - Transcatheter Mitral & Tricuspid Therapies in Irvine, California
This is an exciting opportunity for an exceptional R&D engineering professional with in-depth 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 R&D Manager will lead a fast-paced program in the early stages of development, guide the development of new replacement valve technologies, and collaborate with internal and external partners to define new opportunities for therapy growth. This position will report into the Director of Implant R&D for Transcatheter Mitral and Tricuspid Valve Replacement.
Key responsibilities include:
Lead engineering team in support of product development and ensure all work is performed per internal, ISO and regulatory standards.
Manage a team of R&D resources and product development projects.
Provide timely and innovative resolutions to technical issues that can be called upon from a regulatory perspective.
Provide leadership to engineering core team in the development and implementation of new ideas and concepts for current and future product lines.
Provide updates and recommendations for various inter-departmental issues, as well as program related needs.
Lead the definition, design, prototyping and pre-clinical evaluation of future generation of replacement valves to treat mitral and tricuspid diseases
Identify and prioritize customer needs and translate those into product requirements.
Iterate concepts and refine technologies by working closely with clinical, marketing, engineering, and physician partners in both a pre-clinical and clinical environment
Coordinate and drive alignment with cross-functional teams to achieve team goals and business objectives
Demonstrate 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.
Contribute to the formation and execution of replacement valve strategies as a member of the technical staff
The ideal candidate requires a Bachelor's degree in engineering, mechanical or biomedical is preferred and a minimum 10 years of experience in the medical device industry OR a master's degree in engineering with 8 years of medical device experience.
Experience in new product innovation with successful design from concept to First in Human (FIH)
Clinical and anatomical knowledge with an ability to collaborate with physicians to solicit feedback on new technology
Knowledge and expertise in the Biodesign process or the Design for Six Sigma methodology
Able to demonstrate strong skills as an innovator and communicator.
Proven track record to apply technical knowledge and judgment to complex engineering problems.
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 influence cross-functional partners, business units, and/or sites and may engage with and influence senior management
Displays broad perspective and effective judgment, demonstrates well-reasoned problem solving and decision-making.
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.
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.