Design Assurance Engineer
- Galway
- Permanent
- Full-time
- 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.
- 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.