Design Quality Engineer New
2 weeks ago
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 3 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? Get in touch with me : [email protected]
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