Senior Technical Lead for Medical Device Development

2 days ago

Dublin, Dublin City, Ireland beBeeAssociate Full time €100,000 - €120,000

As a seasoned R&D leader, we are seeking an Associate Director to oversee Verification & Validation (V&V) activities in support of new product development (NPI) and lifecycle management of medical devices.

This position is highly suitable for those with a strong background in developing and qualifying test systems and methods, as well as hands-on experience with design verification/validation for mechanical or electromechanical medical devices.

The successful candidate will lead and mentor a small team of V&V engineers, driving all verification and validation activities. They will develop and optimize physical test methods, fixtures, and systems to support product development and changes.

Key Responsibilities:

  • Lead and mentor a small team of V&V engineers, driving all verification and validation activities.
  • Develop and optimize physical test methods, fixtures, and systems to support product development and changes.
  • Author technical reports, work instructions, and validation documentation.
  • Execute and oversee test method validation (TMV), design verification, and transfer activities.
  • Write and manage verification protocols to ensure compliance with regulatory and quality system requirements.
  • Perform functional and performance testing of medical devices.
  • Collaborate with cross-functional teams, suppliers, and partners to achieve V&V deliverables.
  • Analyze and interpret test data, identifying out-of-spec results and supporting investigations.
  • Ensure test equipment and methods are validated in line with business and regulatory standards.
Qualifying Criteria:
  • 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, etc.).
  • Hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
  • Proficiency in statistical data analysis tools (e.g., Gage R&R, Hypothesis Testing, Tolerance Analysis, Minitab, SAS).
  • In-depth knowledge of regulatory standards (FDA 21 CFR Part 820, EU MDR).
  • Extensive understanding of risk-based validation approaches.

Skills & Attributes:

  • Strong leadership and team development abilities.
  • Excellent organizational, communication, and problem-solving skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Highly collaborative, with advanced technical and managerial judgment.
  • Self-driven, detail-oriented, and results-focused.

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