Design Quality Engineer II — 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]
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