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Design Assurance Engineer

  • Division: Engineering
  • Contact Email: amy.newell@collinsmcnicholas.ie
  • Job Ref: 24697

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