Principal Heart Valves Engineer Job Description
Lead the development of a breakthrough heart valve replacement device. The role involves detailed design and development from concept to clinical studies.
* Leverage knowledge of material development, nitinol, and valve interface requirements.
* Ensure design and development activities meet regulatory requirements.
* Generate detailed drawings and designs using SolidWorks.
The ideal candidate will have a strong background in mechanical or biomedical engineering with experience in stent design, polymer processing, and/or heart valves.
* A minimum of 5 years of experience in medical device process development/R&D is required.
* Proficiency in SolidWorks modelling and engineering drawings is essential.
* Familiarity with FEA/CDF towards implant development is desirable.
* Direct Class III implant design experience and understanding of regulatory requirements are necessary.
Maintain high standards of documentation, generate test protocols and technical reports, and contribute to project planning and risk management activities.