Cardiac Valve Development Opportunity
The successful candidate will join a dynamic team in Galway, Ireland, to lead the development of a breakthrough heart valve replacement. This is a pivotal role that requires expertise in material science, nitinol, and valve interface requirements and test methodologies.
* Leverage knowledge of material development, nitinol, and valve interface requirements to drive innovation in heart valve design.
* Ensure design and development activities meet regulatory requirements per ISO 5840 and clinical end-user needs.
* Generate detailed component and subsystem drawings/designs using SolidWorks.
* Lead research candidates in implant development, including in silico and in vitro testing.
* Maintain accurate records of design iterations, evaluations, and test methods.
* Conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
* Develop bench test methods, including hands-on testing and builds.
* Document work during all project phases to support overall project requirements/deliverables and IP/patent disclosures.
* Generate R&D test protocols & technical reports.
* Complete comprehensive analysis of test data using statistical tools.
* Provide engineering support for pre-clinical trials and commercial readiness.
Requirements:
* Minimum 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.
* Demonstrated proficiency with SolidWorks modelling and engineering drawings.
* Familiarity with application of FEA / CFD towards implant development preferable.
* Direct Class III implant design experience.
* Understanding of regulatory requirements, including ISO 5840, ISO 13485, and FDA regulation.
We offer a collaborative and innovative work environment.