Edwards Lifesciences Senior Engineer, R&D - Transcatheter Heart Valves in Irvine, California
We are looking for a Senior Engineer for Edwards Lifesciences' Transcatheter Heart Valve (THV) integration team. This team is responsible for the interaction and integration of system-level components of the next generation THV platform (Valve, Delivery System, Crimper, Sheath, Preparation components) with each other and the surrounding anatomy.
The Senior Engineer will be responsible for assessing the interaction of the sheath and the system by means of developing and evaluating different test methods , simulated use models, and usability studies . The Senior Engineer will be involved in integrating voice-of-customer , clinical knowledge, and employ deep R&D understanding to support the development of current and future devices. The Senior Engineer involves working closely with a broad cross-functional team that includes Valve and Delivery System R&D, quality, clinical affairs, regulatory affairs, operations and marketing, as well as interacting with clinical specialists and physicians.
Develop test methods and models to simulate interaction of the system with the anatomy and the user
Generate engineering models and prototypes to characterize product
Conduct experiments and DOEs to assess and demonstrate system performances
Analyze results, make recommendations, and generate reports
Present to cross functional team and program management
Lead root cause analyses
Bachelor’s degree in Mechanical or Biomedical Engineering
4+ years of hands on experience is required
2+ years of experience in the medical device industry is required
Experience with developing / testing medical device and the related clinical application
Proven problem-solving, analytical and critical thinking skills
Ability to work in a dynamic environment, quickly adopting to changes
Self driven, ambitious, well rounded personality
Experience with Catheters or Prosthetic Heart Valve design or Sheath is highly preferred.
Ability to interact professionally with all organizational levels and all functions
Strong communication (e.g., written and verbal) and interpersonal relationship skills
Basic understanding of statistical techniques
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.