Senior Engineer, R&D - Transcatheter Heart Valves
- Irvine, CA
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
E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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