R&D Director

20 hours ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €90,000 - €120,000
Senior Technical Lead Opportunity

We are seeking an accomplished Senior Technical Lead to join our engineering team. This is a permanent position based in South Dublin, offering the chance to drive technical excellence and lead a small team of Verification and Validation engineers.

This role involves overseeing verification and validation activities in support of new product development (NPI) and lifecycle management of medical devices. The ideal candidate will have extensive experience in leading technical teams and developing qualified test systems and methods.

  1. Lead and mentor a small team of V&V engineers, driving all verification and validation activities.
  2. Develop and optimize physical test methods, fixtures, and systems to support product development and changes.
  3. Author technical reports, work instructions, and validation documentation.
  4. Execute and oversee test method validation (TMV), design verification, and transfer activities.
  5. Write and manage verification protocols to ensure compliance with regulatory and quality system requirements.
  6. Perform functional and performance testing of medical devices.
  7. Collaborate with cross-functional teams, suppliers, and partners to achieve V&V deliverables.
  8. Analyse and interpret test data, identifying out-of-spec results and supporting investigations.
  9. Ensure test equipment and methods are validated in line with business and regulatory standards.
Requirements
  • Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
  • 10+ years of experience in medical devices, pharmaceuticals, or life sciences.
  • Proven experience leading technical teams.
  • Strong background in developing and qualifying test systems and methods (IQ, OQ, MSA).
  • Hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
  • Proficiency in statistical data analysis tools (Gage R&R, Hypothesis Testing, Tolerance Analysis).
  • In-depth knowledge of regulatory standards (FDA 21 CFR Part 820, EU MDR).
  • Extensive understanding of risk-based validation approaches.

This is a highly collaborative role, requiring advanced technical and managerial judgment. Self-driven, detail-oriented, and results-focused individuals are encouraged to apply.

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