Lead Heart Valve Implant Engineer
We are seeking a senior heart valve engineer to join our team to work on the development of a breakthrough heart valve replacement. Reporting to the Chief Technical Officer, this position will oversee detailed design and development of a next-generation aortic valve replacement device from concept through to clinical studies.
Key Responsibilities:
1. Leverage an in-depth understanding of material science, nitinol, and valve interface requirements and test methodologies to develop implantable devices.
2. Ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user needs.
3. Generate detailed component and subsystem drawings/designs using CAD software.
4. Mentor junior engineers engaged in implant development activities including in silico and in vitro testing: FEA, CFD, FSI, hemodynamic performance analysis, etc.
5. Maintain detailed records of design iterations, evaluations, test methods, and analysis.
6. Create prototypes and conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
7. Develop effective bench test methods including conducting hands-on testing and builds.
8. Maintain high standards of documentation throughout project phases to support overall project deliverables and intellectual property/patent disclosures.
9. Generate R&D test protocols & technical reports.
10. Analyze test data using statistical tools such as Minitab.
11. Interpret results and generate detailed technical reports.
12. Provide engineering support for pre-clinical trials and commercial readiness.
13. Support activities on user evaluation studies to gather insight/feedback on device performance and refine product designs as required.
14. Collaborate with delivery system development partners to optimize deployment of next generation valve implant.
15. Primary contributor to cross-functional team risk management activities (Hazard Analysis/FMEA) with ownership of implant performance and design actions.
16. Contribute to project planning as part of cross-functional team to effectively identify and manage implant schedule, resourcing, and reporting to meet overall project goals.
17. Contribute to regulatory submissions, pre-submissions, and reviews with implant design and performance expertise.
18. Stay up-to-date with emerging technologies and designs to identify opportunities for innovation and improvement.
19. Capture innovative design features through Invention Disclosure Forms and support compilation of patent applications as required.
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Requirements:
20. Minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer).
21. Experience in stent design, polymer processing, and/or heart valves.
22. 5+ years of medical device process development/R&D experience.
23. Proficiency with CAD modeling and engineering drawings.
24. Familiarity with application of FEA/CFD towards implant development preferable.
25. Direct Class III implant design experience.
26. Understanding of regulatory requirements including ISO 5840, ISO 13485, and FDA regulation.
27. Able to develop product-driven bench test methods and perform hands-on testing diligently.
28. Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers.