Heart Valve Development Engineer

1 week ago

Galway, Galway, Ireland beBeeEngineer Full time €100,000 - €120,000
Job Overview

We are seeking an exceptional Heart Valve Development Engineer to lead the development of a breakthrough heart valve replacement device from concept to clinical studies.

Main Responsibilities:
  • Leverage in-depth knowledge of material development, nitinol, and valve interface requirements and test methodologies to drive innovation.
  • Ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end-user needs.
  • Create detailed component and subsystem drawings/designs using SolidWorks.
  • 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.
  • Develop effective bench test methods including conducting hands-on testing and builds.
  • Provide engineering support for pre-clinical trials and commercial readiness.
  • 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.
Qualifications/Skills:
  • 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.

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