Design Assurance Expert

2 weeks ago

Galway, Galway, Ireland beBeeDesign Full time €60,000 - €80,000

We are seeking a skilled Design Assurance Engineer to join our team in Galway. This is an exciting opportunity for a talented professional to contribute to the development of high-quality medical devices.

Key Responsibilities:

  • Ensure product compliance throughout the product lifecycle.
  • Implement design/material changes aligned with regulatory and internal standards.
  • Collaborate with R&D and Manufacturing teams to drive process improvements.
  • 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, 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.

Requirements:

  • 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, sterilisation, usability, human factors, risk management, and statistical analysis.
  • Familiarity with post-market surveillance and CAPA.
  • Excellent communication, analytical, and documentation skills.
  • Detail-oriented, proactive, and effective in fast-paced, team-based environments.

For more information on this role, please contact us.

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