Design Quality Engineer

Design Quality Engineer II Location: Enniscorthy, Co. Wexford Type: Permanent, Full time Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products meet the highest standards. What You’ll Do

• Work closely with design, manufacturing, regulatory affairs, and compliance teams.
• Lead risk assessments on new devices, using FMEA tools to stress-test designs.
• Provide quality support across R&D, design, validation, and test methods.
• Review design documentation to ensure compliance with ISO 13485, ISO 14971, and CFRs.
• Perform statistical analysis and DOE to optimise products and processes.
• Support studies through different testing phases, ensuring design robustness.
• Contribute to biocompatibility assessments, protocol writing, and method validation.
• Engage in internal and supplier audits, driving continuous improvement.

What We’re Looking For

• Degree in Engineering, Science, or Technical discipline.
• Minimum 5 years’ experience in medical devices or pharmaceuticals.
• Strong knowledge of risk management and regulatory compliance.
• Experience with FMEA and other risk management tools (FMS experience an advantage).
• Skilled in statistics, validation, and test methods.
• Proven ability to challenge and stress-test designs to ensure product robustness.
• Strong communicator, able to work cross-functionally and independently.

What’s On Offer

• Flexitime with Monday–Thursday on site in Enniscorthy, and Friday morning from home.
• Join a dynamic, multidisciplinary team working at the interface of design, quality, and compliance.
• Exposure to cutting-edge development across multiple testing phases.
• A varied role where no two days are ever the same.
• Competitive salary and benefits package.

👉 Interested? Contact [email protected]