Lead the development of a next-generation heart valve replacement device from concept to clinical studies.
Key Responsibilities:
* Leverage expertise in material development, nitinol, and valve interface requirements to drive design decisions.
* Ensure designs meet regulatory requirements (ISO 5840) and end-user needs.
* Develop detailed component drawings using SolidWorks and lead cross-functional teams on design iterations.
* Mentor postdoctoral research candidates on implant development activities, including testing methodologies.
* Conduct feasibility studies to evaluate valve designs and materials.
* Develop effective bench test methods and analyze results using statistical tools (Minitab).
* Support pre-clinical trials and commercial readiness efforts.
* Collaborate with delivery system partners to optimize deployment techniques.
Requirements:
* Bachelor's degree in Mechanical, Biomedical, or Polymer Engineering.
* 5+ years of medical device R&D experience, preferably with stent design, polymer processing, and/or heart valves.
* Demonstrated proficiency with SolidWorks and experience with FEA/CDF for implant development.
* Direct Class III implant design experience and understanding of regulatory requirements.
* Strong technical leadership skills and ability to mentor graduate engineers and technicians.