Lead Valve Development Specialist
This role focuses on pioneering next-generation heart valve implants through detailed design, development, and testing.
The successful candidate will lead the creation of innovative valve replacement devices from concept to clinical trials.
* Develop in-depth knowledge of material science, nitinol, and valve interface requirements.
* Ensure compliance with regulatory standards (ISO 5840) and user requirements.
* Design and generate component drawings using SolidWorks.
* Lead a team of engineers and technicians in implant development activities, including in silico and in vitro testing.
* Maintain accurate records of design iterations and test methods.
* Conduct feasibility studies to evaluate valve designs and materials.
* Develop effective bench test methods for hands-on testing and builds.
* Document work throughout project phases for IP/patent disclosures.
* Generate R&D test protocols and technical reports.
* Analyze test data using statistical tools like Minitab.
* Interpret results and create detailed technical reports.
* Provide engineering support for pre-clinical trials and commercial readiness.
* Collaborate with partners to optimize deployment of next-generation valves.
* Manage risk associated with implant performance and design actions.
* Participate in cross-functional teams to plan and manage implant schedules.
* Contribute to regulatory submissions and reviews with expertise in implant design and performance.
* Stay current with emerging technologies and designs to identify opportunities for innovation.