Design Assurance Engineer

Design Assurance Engineer (12-Month Contract) About Your New Employer

• 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.

About Your New Job

• 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.

What Skills You Need

• 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.

Experience with Catheter or Stent technologies, or in cleanroom/vascular device design, is a distinct advantage.

What's on Offer

• 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.