Senior Medical Device Validation Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeTechnical Full time €95,000 - €115,000
Lead Technical Expert for Medical Devices

Job Overview:

The successful candidate will oversee Verification and Validation activities in support of new product development (NPI) and lifecycle management of medical devices. As a technical leader, they will be responsible for driving all verification and validation activities.

Key Responsibilities:

  • 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.
  • 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.

Required Skills and Qualifications:

  • 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, 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.

Desirable 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.

What We Offer:

A dynamic and challenging role with opportunities for growth and development.

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