About the Position:
We are seeking an experienced Senior Principal Reliability Engineer to contribute to the development of next-generation medical technologies.
The team is focused on creating innovations that save lives by advancing the diagnosis and treatment of cardiac arrhythmias.
This is a great opportunity to apply your expertise in reliability engineering while making a meaningful impact in a globally regulated industry.
Key Responsibilities:
* Work closely with R&D teams 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 teams 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.
Requirements:
* 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.
Benefits:
* Competitive salary package.
* Opportunity to make a meaningful impact in a globally regulated industry.
* Training, mentorship, and career progression within a collaborative and innovative environment.
Location:
* Galway, County Galway, Ireland.