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Senior R&D Engineer
3 weeks ago
We are seeking a seasoned professional to lead our R&D Engineering team in the medical device industry. This is a permanent position based in South Dublin, Ireland.
The successful candidate will oversee Verification & Validation (V&V) activities in support of new product development and lifecycle management of medical devices. They will lead a small team of V&V engineers, drive all verification and validation activities, and develop and optimise physical test methods, fixtures, and systems to support product development and changes.
Key Responsibilities:
- Lead and mentor a small team of V&V engineers.
- Develop and optimise physical test methods, fixtures, and systems.
- Author technical reports, work instructions, and validation documentation.
- Execute and oversee test method validation, 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.
- Hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
- Proficiency in statistical data analysis tools.
- In-depth knowledge of regulatory standards.
- Extensive understanding of risk-based validation approaches.
Benefits:
- Leadership opportunities.
- Collaborative environment.
- Opportunities for professional growth and development.
Requirements:
- Excellent leadership and technical skills.
- Ability to communicate effectively with cross-functional teams.
- Highly organised, with excellent problem-solving skills.
