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Innovative Heart Valve Development Specialist
3 weeks ago
The role of Innovative Heart Valve Development Specialist plays a pivotal part in the advancement of next-generation heart valve replacement technology. As a key member of our team, you will have the opportunity to drive innovation forward and make a meaningful impact on patients' lives.
This position is responsible for leveraging expertise in material science, nitinol, and valve interface requirements to design and develop cutting-edge aortic valve replacement devices that meet regulatory requirements (ISO 5840) and clinical end-user needs through rigorous testing and analysis.
Key Responsibilities:
- Leverage your expertise in material science, nitinol, and valve interface requirements to design and develop innovative heart valve replacement devices.
- Evaluate and ensure compliance with regulatory requirements (ISO 5840) and clinical end-user needs through thorough testing and analysis.
- Collaborate with cross-functional teams to drive implant development forward and stay up-to-date with emerging technologies.
- Develop comprehensive test protocols and technical reports to support project deliverables and intellectual property protection.
Requirements:
- Bachelor's degree in Mechanical, Biomedical, or Polymer Engineering.
- 5+ years of experience in medical device R&D and process development.
- Proficiency in SolidWorks modeling and engineering drawings.
- Familiarity with FEA/CFD applications and Class III implant design experience.
- Strong understanding of regulatory requirements, including ISO 13485 and FDA regulation.
Why This Role Matters:
This position offers a unique opportunity to shape the future of heart valve replacement technology and contribute to the development of life-changing innovations that improve patient outcomes.