Lead Heart Valve Implant Engineer
We are seeking a seasoned professional to lead the development of a breakthrough heart valve replacement device.
This position involves leading detailed design and development from concept through to clinical studies, ensuring all activities meet required regulatory requirements and clinical end-user needs.
Role/Responsibilities:
1. Leverage expertise in material development, nitinol, and valve interface requirements to drive innovative solutions.
2. Manage design and development activities, including component and subsystem drawings/designs using SolidWorks, to ensure compliance with ISO 5840 and user needs.
3. Lead and mentor postdoctoral research candidates engaged in implant development, including in silico and in vitro testing: FEA, CFD, FSI, hemodynamic performance analysis, etc.
4. Maintain detailed records of design iterations, evaluations, test methods, and analysis.
5. Develop prototypes and conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
6. Design effective bench test methods and conduct hands-on testing and builds.
7. Maintain high standards of documentation throughout project phases to support overall project requirements/deliverables and IP/patent disclosures.
8. Generate R&D test protocols & technical reports.
9. Analyze test data using statistical tools like Minitab and provide detailed technical reports.
10. Support pre-clinical trials and commercial readiness with engineering expertise.
11. Collaborate with delivery system development partners to optimize deployment of next-generation valve implants.
12. Contribute to cross-functional team risk management activities (Hazard Analysis/FMEA) with ownership of implant performance and design actions.
13. Participate in project planning as part of cross-functional team to effectively identify and manage implant schedule, resourcing, and reporting to meet overall project goals.
14. Support regulatory submissions, pre-submissions, and reviews with implant design and performance expertise.
15. Stay updated with emerging technologies and designs to identify opportunities for innovation and improvement.
16. Document innovative design features through Invention Disclosure Forms and support compilation of patent applications as required.