Design Quality Engineer

2 days ago

Wexford, Ireland Cpl Full time

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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