Principal Heart Valves Engineer



Our client a structural heart startup based in Galway, Ireland are seeking a lead heart valve implant engineer to join their team to work on the development of a breakthrough heart valve replacement. Reporting to the CTO, this position will lead detailed design and development of a next-generation aortic valve replacement device from concept and pre-clinical trial evaluation through to clinical studies.



Role/Responsibilities:

• Leverage an in-depth understanding of material development, nitinol, and valve interface requirements and test methodologies.
• Ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user requirements.
• Generate detailed component and subsystem drawings/designs using SolidWorks.
• Lead and mentor postdoctoral research candidates engaged in implant development activities at our academic partner institution including in silico and in vitro testing: FEA,CFD, FSI, hemodynamic performance analysis, etc.
• Maintain detailed records of design iterations, evaluations, test methods, and analysis.
• Create prototypes and design iterations and conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
• Develop effective bench test methods including conducting hands-on testing and builds.
• Maintain high standard of documentation of 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 such as Minitab.
• Perform in-depth interpretation of results and generate detailed technical reports.
• Provide engineering support for pre-clinical trials and commercial readiness.
• Support activities on user evaluation studies to gather insight / feedback on device performance and refine product designs as required.
• Collaborate with delivery system development partners to optimize deployment of next generation valve implant.
• Primary contributor to cross functional team risk management activities (Hazard Analysis/ FMEA) with ownership of implant performance and design actions.
• 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.
• Contribute as required to regulatory submissions, pre-submissions, and reviews with implant design and performance expertise.
• Stay up to date with emerging technologies and designs to identify opportunities for innovation and improvement.
• File and capture as appropriate innovative design features through Invention Disclosure Forms and support compilation of patent applications as required.

• 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.
• Demonstrated ability to develop product-driven bench test methods and perform hands-on testing diligently.
• Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers.