Chief Heart Valve Technologist

2 weeks ago

Galway, Galway, Ireland beBeeValve Full time €90,000 - €120,000

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.

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