Medical Device Verification Lead

2 days ago

Dublin, Dublin City, Ireland beBeeVerification Full time €120,000 - €140,000

Our organization is looking for a skilled professional to lead our Verification & Validation activities in support of new product development and lifecycle management of medical devices. The ideal candidate will have experience overseeing teams, developing test methods, and authoring technical reports.

About the Role:
  • Lead and mentor a team of V&V engineers, driving 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.
Skill 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, 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).
Key Qualifications:
  • Excellent leadership and team development abilities.
  • Strong 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.

The ideal candidate will be responsible for ensuring that all V&V activities are completed on time and within budget. They will also be responsible for collaborating with cross-functional teams to achieve V&V deliverables.

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