Senior Design Assurance Engineer

Position: Senior Design Assurance Engineer

We are partnering with a growing medical device company to appoint a Senior Design Assurance Engineer in Galway. This role will give you the chance to take ownership of QA activities across the full product lifecycle, from design and development through to commercialisation.

Key Responsibilities

• Lead risk assessments, design verification/validation, and DHF management.

• Review and approve technical documentation in line with ISO 13485 and FDA 21 CFR Part 820.

• Act as SME for audits and regulatory inspections.

• Partner with R&D and Manufacturing Engineering to translate design requirements into manufacturing processes.

• Support CAPA, audits, and continuous improvement activities.

• Mentor junior staff and provide QA guidance across teams.

Essential Skills & Experience

• Bachelor’s degree in Engineering, Science, or related field.

• 5+ years’ QA/RA experience in the medical device industry.

• Strong background in design assurance and product development.

• In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR.

• Experience supporting notified body/FDA inspections.

• Strong communicator, problem solver, and team player.