Senior Heart Valve Development Specialist

6 days ago

Galway, Galway, Ireland beBeeHeartValve Full time €120,000 - €150,000
Heart Valve Implant Development Lead

We are seeking a highly skilled and experienced heart valve implant engineer to lead the development of next-generation aortic valve replacement devices.

This position will oversee the detailed design and development of breakthrough heart valve replacement technology from concept through clinical studies.

  • Leverage expertise in material development, nitinol, and valve interface requirements and test methodologies.
  • Ensure all design and development activities meet required regulatory standards per ISO 5840 and clinical end-user specifications.

The ideal candidate will have:

  • A minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer) degree.
  • Experience in stent design, polymer processing, and/or heart valves.
  • 5+ years of medical device process development/R&D experience.

Key skills include:

  • Demonstrated proficiency with SolidWorks modeling and engineering drawings.
  • Familiarity with application of FEA/CFD towards implant development preferable.
  • Direct Class III implant design experience.

Responsibilities will include:

  • Leading cross-functional team risk management activities (Hazard Analysis/FMEA).
  • Conducting comprehensive analysis of test data using statistical tools such as Minitab.
  • Providing engineering support for pre-clinical trials and commercial readiness.

Required Skills and Qualifications

The ideal candidate will possess a strong understanding of:

  • Regulatory requirements including ISO 5840, ISO 13485, and FDA regulations.
  • Material development, nitinol, and valve interface requirements and test methodologies.

What We Offer

This role offers a challenging and rewarding opportunity for innovation and growth. If you are a motivated and experienced engineer looking to make a difference in the field of heart valve replacement, we encourage you to apply.

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