Chief Heart Valve Development Specialist

20 hours ago

Galway, Galway, Ireland beBeeHeart Full time €95,000 - €115,000

Job Title: Chief Heart Valve Development Specialist

Job Description:

This is a key role that will lead the development of next-generation heart valve replacement devices. The successful candidate will have a deep understanding of material development, nitinol, and valve interface requirements.

The individual in this position will be responsible for generating detailed component and subsystem drawings/designs using SolidWorks and ensuring all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user requirements.

Responsibilities include:

  • Leverage an in-depth understanding of material development, nitinol, and valve interface requirements and test methodologies.
  • 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 standards 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.

Key Qualifications:

  • Bachelor of Engineering (Mechanical/Biomedical/Polymer) or higher degree in relevant field.
  • Experience in stent design, polymer processing, and/or heart valves.
  • At least 5 years of medical device process development/R&D experience.
  • Demonstrated proficiency with SolidWorks modeling 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.

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