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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Principal Heart Valves Engineer


Reference:JCAO0401 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Principal Engineer, Senior Research and Development Engineer

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.


Skills/Experience
  • 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.


For further information contact James Cassidy [email protected] or call in confidence 086 0204322