Design Assurance Engineer About Your New Employer Work with a global leader in medical device innovation, renowned for cutting-edge research and development. Join an established project team in Galway, partnering cross-functionally in a supportive and collaborative work environment. Shape the future of healthcare by supporting the development of advanced medical devices. This is a 12 month PAYE Temp position through Sigmar Recruitment. About Your New Job As a Design Assurance Engineer, you will independently plan, execute, and lead Design Verification (DV) testing to ensure new medical devices meet demanding regulatory and quality standards. You will drive the preparation, execution, and review of audit-ready test protocols and technical reports, fully compliant with internal Quality Systems and regulatory requirements. Take charge of conducting Gauge R&R studies, developing and validating test methods, and performing advanced statistical analysis on data. Act as the DA representative, collaborating closely with R&D, Packaging, Labeling, and Regulatory Affairs in a hybrid onsite/remote environment. Play a key role in risk management activities to identify, communicate and mitigate risks related to device design and use (ISO 13485/FDA 21 CFR Part 820 compliance). Engage actively with the DA team and Project Manager, progressing project milestones, troubleshooting process exceptions, and ensuring timely project delivery. What Skills You Need Level 8 degree in a STEM discipline (preferably Biomedical or Mechanical Engineering). 35+ years experience in a Design Assurance or Quality Engineering role within the medical device industry. Demonstrable experience authoring, executing, and interpreting complex verification protocols and technical reports. Strong technical skills in Gauge R&R, test method development, and statistical data analysis. Practical working knowledge of ISO 13485 and FDA 21 CFR Part 820 regulatory standards. Excellent communication and stakeholder management skills, with the ability to operate autonomously. Preferred/Desirable: Experience with catheter, stent, or vascular device technologies. Practical understanding of clean room environments and design controls. What's on Offer Competitive daily/hourly rate for a 12-month contract (details available on application). Hybrid working model (23 days onsite in Galway, with scheduling flexibility based on project phase). Join a highly skilled, cross-functional team, with exposure to advanced technologies and impactful product development. Opportunities to enhance your regulatory, technical, and leadership skills in a world-class organization. What's Next Apply now by clicking the Apply Now\" button or contact us directly to discuss this role further. If this position doesnt align with your profile but you have relevant experience, please get in touch to explore additional contract/temporary opportunities in the medical device sector. Skills: \"CAPA\" \"Medical Device\" \"Quality Engineering\"
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