Principal Reliability Engineer
Galway
Permanent
Permanent
Principal Reliability Engineer
Cardiac Ablation Solutions | Galway
About the Role
We 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 Do
This 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.
Cardiac Ablation Solutions | Galway
About the Role
We 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 Do
- Partner 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.
- A 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.
This 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.
