We’re partnering with a Galway-based medical device company to support their search for a Design Assurance Engineer. This is a fantastic opportunity to join an innovative and collaborative team focused on delivering high-quality, life-changing products. The successful candidate will play a key role in ensuring product compliance, driving design changes, and supporting post-market activities.
Responsibilities:
- Support sustaining projects and ensure compliance throughout the product lifecycle.
- Lead and implement design/material changes aligned with regulatory and internal standards.
- Provide input on process changes with R&D and Manufacturing teams.
- Apply risk management per ISO 14971 and ISO 13485.
- Maintain risk files for post-market products.
- Plan and execute design verification and shelf-life testing.
- Ensure design control compliance (e.g., FDA 21 CFR 820.30), including DHF maintenance.
- Support complaint investigations, root cause analysis, and CAPA activities.
- Stay current on regulatory changes and best practices.
- Contribute to documentation including specs, drawings, and procedures.
- Assist in audits and regulatory submissions.
- Work cross-functionally on product updates and improvements.
- Mentor junior engineers and drive continuous improvement.
Qualifications:
- Bachelor’s degree (Level 8 NFQ) in Engineering, Science, or related discipline.
- 2–3 years' experience in design assurance, quality, or product development (medical device industry).
- Strong knowledge of FDA QSR, ISO 13485, and ISO 14971.
- Experience in:
- Design controls and verification
- Biocompatibility and sterilisation
- Usability and human factors
- Risk management and statistical analysis
- Familiarity with post-market surveillance and CAPA.
- Strong communication, analytical, and documentation skills.
- Detail-oriented, proactive, and effective in fast-paced, team-based environments.
For a confidential discussion, a more detailed job spec and more information on the role, please contact Amy Newell.
amy.newell@collinsmcnicholas.ie
091-706718