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:
o Design controls and verification
o Biocompatibility and sterilisation
o Usability and human factors
o 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
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