Lead Heart Valve Implant Development Engineer
* Leverage expertise in material development, nitinol, and valve interface requirements to drive implant design.
* Ensure all design activities meet regulatory standards per ISO 5840 and clinical end user requirements.
* Create detailed component and subsystem drawings/designs using SolidWorks.
* Lead research candidates engaged in implant development including in silico and in vitro testing.
* Maintain records of design iterations, evaluations, test methods, and analysis.
* Develop prototypes and conduct feasibility studies to evaluate valve designs and deployment techniques.
* Design effective bench test methods and conduct hands-on testing.
* Support pre-clinical trials and commercial readiness.
* Collaborate with delivery system partners to optimize next generation valve implant deployment.
* Contribute to risk management activities.
* Stay up-to-date with emerging technologies to identify opportunities for innovation.
* File innovative features through patent applications.
Key Requirements:
* Bachelor of Engineering (Mechanical/Biomedical/Polymer).
* Experience in stent design, polymer processing, and/or heart valves.
* 5+ years of medical device process development/R&D experience.
* Proficiency with SolidWorks modelling and engineering drawings.
* Class III implant design experience.
* Understanding of regulatory requirements.