Principal Reliability Engineer
Galway
Permanent
Permanent
The role works closely with Research & Development in the creation and refinement of test methods, ensuring they are fully prepared for the Test Method Validation (TMV) process.
Reporting to a Quality Core Team Member (QCTM), the postholder will support the delivery of day-to-day project requirements as an extended member of the quality team. They will also collaborate with engineering and manufacturing functions to ensure that robust quality standards are implemented and maintained.
The role includes carrying out systematic reliability analysis against features, requirements, architecture, interfaces, and designs. This will involve applying appropriate reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting) to evaluate product and process robustness.
The postholder will be expected to demonstrate a strong understanding of risk management principles and their application within quality systems, ensuring compliance with FDA requirements as well as ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO 13485:2016 standards.
In addition, the role involves leading strategies for test method validations, design verification, and the development of shelf-life protocols and reports.
Key Skills and Experience
Reporting to a Quality Core Team Member (QCTM), the postholder will support the delivery of day-to-day project requirements as an extended member of the quality team. They will also collaborate with engineering and manufacturing functions to ensure that robust quality standards are implemented and maintained.
The role includes carrying out systematic reliability analysis against features, requirements, architecture, interfaces, and designs. This will involve applying appropriate reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting) to evaluate product and process robustness.
The postholder will be expected to demonstrate a strong understanding of risk management principles and their application within quality systems, ensuring compliance with FDA requirements as well as ANSI/AAMI/ISO 14971:2019 and ANSI/AAMI/ISO 13485:2016 standards.
In addition, the role involves leading strategies for test method validations, design verification, and the development of shelf-life protocols and reports.
Key Skills and Experience
- Advanced knowledge of the field, typically acquired through higher education combined with significant professional experience.
- Minimum of a Level 8 Degree in Engineering or a related discipline with at least 7 years of relevant experience, or an advanced degree with a minimum of 5 years of experience.
- Practical knowledge of project management is advantageous.
- Experience in a highly regulated industry, preferably medical devices.
- Demonstrated ability to resolve complex issues through collaboration with cross-functional teams.
- Proven ability to work effectively within a matrix organisation and navigate complex business systems, regulations, standards, and performance requirements.
- Knowledge of reliability tools and practices supporting requirements, design, integration, verification, and validation.
- Strong critical thinking skills with a focus on enhancing system performance and driving positive business outcomes.
- Excellent communication and influencing skills, essential for success in this role.
