Lead Heart Valve Implant Development Expert

2 days ago

Galway, Galway, Ireland beBeeHeartValveEngineer Full time €90,000 - €105,200

This is a role that will have significant impact on the future of heart valve implants.

">Job Title: Lead Heart Valve Implant Engineer

We are seeking an experienced engineer to join our team and work on the development of breakthrough heart valve replacement solutions. The ideal candidate will have in-depth knowledge of material development, nitinol, and valve interface requirements.

">Responsibilities:", "
  • ", "
  • Leverage expertise in stent design, polymer processing, and heart valves to drive innovation.","
  • Collaborate with cross-functional teams to ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user needs.","
  • Design and develop product-driven bench test methods and perform hands-on testing diligently.","
  • 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.","
  • Generate R&D test protocols & technical reports.","
  • Develop effective tools for 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."]", "
", "

Our ideal candidate will have a strong background in medical device process development/R&D and demonstrated proficiency with SolidWorks modelling and engineering drawings.

", "Qualifications/Skills:", "
  • ", "
  • Minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer).","
  • Demonstrated experience in stent design, polymer processing, and/or heart valves.","
  • 5+ years of medical device process development/R&D experience.","
  • 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.","
  • Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers."]","
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