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Associate Director - R&D Engineering (Medical Device)

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  • Division: Engineering
  • Contact Email: ranait.coughlan@collinsmcnicholas.ie
  • Job Ref: 24738

The Role: Associate Director - R&D Engineering (Medical Device)

We are working in partnership with a Global Medical Device Company to hire an Associate Director for their Engineering department. The successful person will oversee Verification & Validation (V&V) activities in support of new product development (NPI) and lifecycle management of medical devices. This opportunity is highly suitable for a seasoned R&D leader within the medical device industry. It is a permanent position based in South Dublin.

Key Responsibilities:

  • Lead and mentor a small team of V&V engineers, driving all verification and validation activities.
  • Develop and optimise 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.
  • Analyse 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.
  • Support standards and requirements management to ensure compliance with the latest regulations.

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.
  • Willing and eligible to travel overseas when required.

Skills & Attributes:

  • Strong leadership and team development abilities.
  • Excellent organisational, 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.

If you're an R&D Engineer and interested in a confidential discussion about this Associate Director role in South Dublin, you can contact Ranait Coughlan.

ranait.coughlan@collinsmcnicholas.ie

(090) 6450664 | (01) 66 200 88