Principal Heart Valves EngineerOur client, a structural heart startup based in Galway, Ireland, is 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.ResponsibilitiesLeverage 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.Qualifications / SkillsMinimum 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.For further information contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322
#J-18808-Ljbffr