Edwards Lifesciences R&D Staff Engineer - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
This is a great opportunity for an outstanding R&D professional with experience in the medical device industry to join a team that is ambitiously 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 role is part of the fast-paced, innovative, PASCAL project—a transcatheter valve repair technology. The desired candidate will play a pivotal role on the R&D team, specifically on the newly commercialized PASCAL device. This position offers ownership of development and sustaining projects focused on commercial implant devices.
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, ambitious, and rewarding environment that offers potential for growth and professional advancement for the right candidate
This position provides expertise in the optimization of product development.
Lead and drive changes required for the commercial PASCAL implant
Train, mentor, and guide lower level employees on standard engineering practices
Work with the complaints team to provide R&D review and analysis of complaints
Provide R&D support for transfer of device manufacturing to commercial production lines
Develop and execute engineering project plans
Write protocols, reports, and technical summaries
Execute and support design verification testing
Identify, evaluate, manage, and provide guidance to suppliers
Defining acceptance criteria for suppliers and establishing tolerances and specification
Work in both a pre-clinical and clinical environment to evaluate technology
Gain intimate understanding of cardiovascular anatomy and structure heart and valve diseases
Collaborate with Manufacturing, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and external policies and procedures (QSR, FDA Regulations, and ISO Standards).
Education and Experience:
Bachelor's Degree in Engineering or Scientific field with minimum of 6 years of experience, including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field with minimum of 5 years of experience, including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field with minimum of 2 years of experience, including either industry or industry/education Required
Effective communication, listening, and diagnostic skills, verbal and written
Proficiency in the usage of relevant computer software
Excellent documentation and communication skills
Excellent interpersonal relationship skills including negotiating/relationship management skills
Ability to manage competing priorities in a fast-paced environment
Ability to work well independently and as a member of a team is essential
Ability to interact professionally with all organizational levels
The candidate must also be comfortable interacting with leading cardiologists and surgeons
Proven track record in applying apply technical knowledge and judgment to complex engineering problems
Experience with nitinol-based implants is strongly preferred
Experience in a commercial environment is strongly preferred
Basic understanding of statistical techniques
Strong problem-solving, organizational, analytical and critical thinking skills
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.