Design Assurance Engineer
CREGG are hiring for a Design Assurance Engineer to join a leading medical device company in Galway. Multiple positions available at Engineer II, III and Senior levels.
Role Summary
The successful candidate will partner with R&D, Manufacturing, Quality, and Regulatory Affairs teams to ensure medical devices are designed, developed, verified, validated, and transferred to production in compliance with applicable regulations and quality standards. The role supports risk management, design controls, process validation, and continuous improvement activities to ensure safe and effective products for patients.
Key Responsibilities
Design Controls & Product Development
- Support product development activities from concept through commercialization.
- Ensure compliance with design control requirements and quality system regulations.
- Review and approve design documentation, including design inputs, outputs, verification, validation, and design reviews.
- Maintain design traceability throughout the product lifecycle.
- Participate in design transfer activities to manufacturing.
Risk Management
- Facilitate and maintain risk management activities in accordance with ISO 14971.
- Support hazard analyses, risk assessments, and Failure Modes and Effects Analysis (FMEA).
- Ensure identified risks are mitigated and documented appropriately.
Verification & Validation
- Develop and review validation strategies and protocols.
- Support execution and approval of:
- Design Verification
- Design Validation
- Process Validation
- Test Method Validation
- Equipment Qualification (IQ/OQ/PQ)
- Ensure objective evidence demonstrates compliance with design requirements.
Quality & Regulatory Compliance
- Ensure compliance with:
- U.S. Food and Drug Administration Quality System Regulations
- International Organization for Standardization ISO 13485
- EU Medical Device Regulation (MDR)
- Internal quality procedures
- Support internal and external audits and regulatory inspections.
- Participate in change control and nonconformance investigations.
Continuous Improvement
- Analyze quality and process data to identify improvement opportunities.
- Support CAPA activities and root cause investigations.
- Drive process improvements using Lean Six Sigma and risk-based methodologies.
Cross-Functional Collaboration
- Work closely with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, Clinical, and Operations teams.
- Provide quality and compliance guidance throughout development projects.
- Support new product introductions and technology transfer activities.
Qualifications
Education
- Bachelor's degree in:
- Biomedical Engineering , Mechanical Engineering , Electrical Engineering, Manufacturing Engineering or Quality Engineering
- Related engineering discipline
Experience
- 3–8+ years of experience in medical devices, pharmaceuticals, biotechnology, or a regulated industry.
- Experience with product development and design controls preferred.
For more information contact Mark: 086 190 1346 or [email protected]
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