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Associate director - r&d engineering (medical device)

Dublin
Collins McNicholas Recruitment
Associate director
Posted: 12h ago
Offer description

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
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