Overview
Senior Principal Reliability Engineer – Cardiac Ablation Solutions – Galway, Ireland (on-site, minimum 4 days per week).
Responsibilities
* Work closely with R&D to develop test methods and ensure readiness for Test Method Validation (TMV).
* Validate TMVs in line with required procedures and standards.
* Partner with quality core team members to deliver day-to-day project outcomes.
* Collaborate with engineering and manufacturing to ensure robust quality standards.
* Perform systematic reliability analysis using tools such as fault tree analysis, failure trending, and forecasting to assess product and process robustness.
* Apply risk management concepts in line with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
* Lead strategies for test method validations, design verification, and shelf-life protocols/reports.
Skills & Experience
* Level 8 Degree in Engineering (or relevant discipline) with 10+ years’ relevant experience, or an advanced degree with 8+ years’ experience.
* Strong knowledge of reliability engineering tools and practices across requirements, design, integration, verification, and validation.
* Background in a highly regulated industry, ideally medical devices.
* Proven ability to solve complex issues in collaboration with cross-functional teams.
* Strong communication skills with the ability to influence at all levels.
* Experience in a matrix organization, navigating business systems, regulations, standards, and performance requirements.
* Project management knowledge is an advantage.
* Demonstrated critical thinking skills with focus on improving system performance and delivering measurable business impact.
What’s on Offer
* Competitive salary package
* Flexible benefits
* Opportunity to make a meaningful impact in a globally regulated industry
* Training, mentorship, and career progression within a collaborative and innovative environment
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