Design Assurance Engineer
Sigmar Recruitment View all jobs
- Galway
- €60,000 per year
- Permanent
- Full-time
- Join a high-achieving team dedicated to cutting-edge medical device innovation.
- Collaborate with multidisciplinary experts in a dynamic and supportive work culture.
- Gain valuable experience on a high-impact project in a global MedTech hub, Galway.
- As the Design Assurance Engineer you will plan, execute, and lead rigorous Design Verification (DV) testing to ensure new devices meet all specifications.
- Independently author, review, and execute test protocols and reports, guaranteeing documentation is “audit-ready” and aligned with the latest regulatory standards.
- Conduct complex statistical analyses (including Gauge R&R), validate test methods, and provide risk management input.
- Serve as the DA representative, collaborating daily with R&D, Packaging, Labeling, and Regulatory Affairs, ensuring cross-functional alignment and project momentum.
- Proactively identify and resolve complex technical exceptions, supporting the DA team to meet project milestones within tight deadlines.
- Degree in a STEM discipline (Biomedical or Mechanical Engineering preferred).
- 3+ years’ experience in Design Assurance or Quality Engineering within the medical device industry.
- Demonstrated expertise in authoring/executing complex DV protocols and reports, Gauge R&R, and statistical analysis.
- Knowledge and practical application of ISO 13485 and FDA 21 CFR Part 820.
- Strong autonomy, communication skills, and a pragmatic, milestone-focused approach.
- Hybrid working model (2–3 days onsite per week in Galway, flexible based on project needs).
- Direct involvement in core product development phases—your input has real impact.
- Opportunity to further enhance your technical leadership and regulatory expertise in a recognized MedTech environment.