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.

What's Next

Apply now by clicking the “Apply Now” button. If you’re driven, autonomous, and ready to make your mark on a new device in a fast-paced project, we want to hear from you! For more details, contact us directly. If this particular opportunity isn’t the perfect match, please get in touch about similar Design Assurance or Medical Device roles.