Job Title:
Parkmore Reliability Engineer
Location: Galway
Benefits:
* Bonus
* Pension
* Healthcare
* Hybrid working (1 day from home)
This role will be on-site (minimum 4 days per week) based out of Parkmore, Galway site.
Key Responsibilities:
1. Works closely with Research & Development in the development of Test methods to ensure that they are ready for the Test Method Validation process.
2. Ensures all TMVs are validated to meet the required TMV procedure and standards.
3. Takes direction from the quality core team member in delivering day-to-day project deliverables as an extended QCTM.
4. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
5. Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting, etc.) to understand product and process robustness.
6. Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO, and ANSI/AAMI/ISO requirements.
7. You will lead strategies for test method validations, design verification and shelf-life protocols/reports.
Qualifications:
* Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
* Requires a minimum Level 8 Degree in Engineering or other relevant discipline and minimum 8 years of relevant experience.
* Or advanced Degree with a minimum of 7 years of relevant experience.
* May have practical knowledge of project management.
* Experience in a highly regulated industry, preferably medical devices.
* Experience with solving complex issues by interacting with cross-functional groups.
* Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.
* Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation.
* Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact.
* Excellent communication and ability to influence is critical to the role.
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