3 days ago Be among the first 25 applicantsDirect message the job poster from GxP RecruitmentRecruitment Director @ GxP Recruitment | Global RecruitmentSpecialising in Life Science recruitment with expertise in Med Device Manufacturing…Principal Reliability EngineerCardiac Ablation Solutions | GalwayAbout the RoleWe are seeking a Principal Reliability Engineer to join our Client's Cardiac Ablation Solutions team in Galway. In this role, you will play a pivotal part in shaping the future of life-saving technologies by ensuring products meet the highest standards of reliability, safety, and performance. You’ll work at the intersection of R&D, manufacturing, and quality—driving innovation while safeguarding excellence.What You’ll DoPartner with Research & Development to create and refine test methods, preparing them for successful Test Method Validation (TMV).Lead the validation of TMVs, ensuring compliance with all procedures, standards, and regulations.Collaborate across engineering and manufacturing teams to embed robust quality standards into every stage of development.Perform in-depth reliability analysis—from fault tree analysis and failure trending to forecasting—to enhance product and process robustness.Apply risk management principles to meet regulatory requirements (FDA, ISO 13485:2016, ISO 14971:2019, and ANSI/AAMI standards).Drive strategies for test method validations, design verification, and shelf-life protocols/reports, ensuring world-class reliability.Act as an extended member of the Quality Core Team, delivering key project milestones and influencing outcomes.What You BringA Level 8 Degree in Engineering (or equivalent) with 7+ years of relevant experience, or an advanced degree with 5+ years of experience.Expertise in a highly regulated industry—medical devices preferred.Strong knowledge of reliability tools and practices that support requirements, design, integration, and validation.Demonstrated ability to solve complex challenges, working seamlessly across cross-functional teams.Experience operating in a matrix organization, with proven success navigating complex systems and standards.Exceptional critical thinking, communication, and influencing skills, with a track record of driving measurable business impact.Practical knowledge of project management is an advantage.Why Join Our ClientThis is more than just a role—it’s an opportunity to directly contribute to medical innovations that save and improve lives worldwide. You’ll work alongside a passionate team, influence global standards, and have the freedom to innovate in a collaborative environment.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering and ManufacturingIndustries: Manufacturing and Medical Equipment ManufacturingWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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