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Design Assurance Engineer
4 weeks ago
Job Title: Design Assurance Engineer
Location: Galway, Ireland
Department: Quality / Design Assurance
Reporting To: Design Assurance Manager
Type: Full-time, Permanent
Role Overview
A highly motivated and experienced Design Assurance Engineer is sought to support the lifecycle of commercially released medical device products. This key role involves managing design changes, ensuring continued compliance with global standards, and supporting post-market activities such as complaint investigations.
Key Responsibilities
- Provide design assurance input on sustaining engineering projects across the full product lifecycle.
- Lead and execute product/material design changes in compliance with global regulatory and quality system requirements.
- Assess changes for design, usability, sterilisation, biocompatibility, and clinical impact.
- Support process changes in collaboration with R&D and Manufacturing Engineering teams.
- Maintain and update risk management files per ISO 14971 and FDA guidelines.
- Generate and execute Design Verification (DV) plans, protocols, and reports.
- Ensure compliance with design control requirements (FDA 21 CFR 820.30, ISO 13485).
- Maintain design history files (DHF) and ensure full traceability of design documentation.
- Support complaint investigations, root cause analysis, and implementation of CAPAs.
- Stay informed on evolving regulatory requirements affecting product design and development.
- Provide technical input into material specs, inspection criteria, drawings, and manufacturing documentation.
- Contribute to regulatory submissions and audit preparation by providing design assurance documentation.
- Collaborate across departments to document and implement product changes.
- Champion continuous improvement initiatives within the design assurance function.
- Mentor junior engineers when required.
Qualifications & Experience
- Bachelor's degree (Level 8 NFQ or equivalent) in Engineering, Science, or a related technical discipline.
- 2–3 years' experience in design assurance, quality engineering, or product development within the medical device sector.
- Strong working knowledge of ISO 13485, ISO 14971, and FDA QSR.
- Hands-on experience with:
- Design controls and verification activities
- Biocompatibility and sterilisation validations
- Risk management processes
- Human factors and usability assessments
- Experience with post-market quality processes, including complaint handling and CAPA.
- Demonstrated ability to work independently on moderately complex projects with general supervision.
- Strong analytical, communication, and documentation skills.
- Ability to manage multiple priorities in a dynamic, fast-paced environment.
- Effective team player with the ability to influence cross-functional collaboration.
