Design Quality Engineer

• 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.

• 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.

• 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.

Cpl Group