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Job Description
Job Summary: Lead heart valve implant engineer to develop breakthrough heart valve replacement from concept to clinical studies. Leverage material development, nitinol, and valve interface requirements. Ensure regulatory compliance and collaborate with cross-functional teams.
Responsibilities:
- Leverage expertise in material development, nitinol, and valve interface requirements.
- Ensure design and development activities meet regulatory requirements (ISO 5840) and clinical user needs.
- Generate detailed component and subsystem drawings using Solid Works.
- Lead and mentor postdoctoral research candidates in implant development, including in silico and in vitro testing.
- Conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
- Develop effective bench test methods and perform hands-on testing.
- Maintain high standards of documentation and generate R&D test protocols and technical reports.
- Complete comprehensive analysis of test data and provide engineering support for pre-clinical trials and commercial readiness.
Requirements:
- Minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer).
- 5+ years of medical device process development/R&D experience.
- Demonstrated proficiency with Solid Works modelling and engineering drawings.
- Familiarity with FEA / CFD towards implant development.
- Direct Class III implant design experience.
- Understanding of regulatory requirements (ISO 5840, ISO 13485, FDA).