Overview
Senior Principal Reliability Engineer - Cardiac Ablation Solutions at Medtronic. This on-site role is based at Parkmore, Galway, Ireland (minimum 4 days per week).
A Day in the Life
* Works closely with Research & Development in the development of test methods to ensure readiness for the Test Method Validation (TMV) process.
* Ensures all TMV’s are validated to meet the required TMV procedure and standards.
* Takes direction from the quality core team member in delivering day-to-day project deliverables as an extended QCTM.
* Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
* Performs systematic reliability analysis against features, requirements, architecture, interfaces, and designs, applying reliability engineering techniques (e.g., fault tree analysis, failure trending and analysis, reliability forecasting) to understand product and process robustness.
* Understands risk management concepts used throughout the quality system to meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
* Leads strategies for test method validations, design verification, and shelf-life protocols/reports.
Key Skills & Experience
* Advanced knowledge of the job area, combining breadth and depth from education and experience.
* Minimum Level 8 Degree in Engineering or relevant discipline with at least 10 years of relevant experience, or advanced degree with at least 8 years of relevant experience.
* Practical knowledge of project management is a plus.
* Experience in a highly regulated industry, preferably medical devices.
* Experience solving complex issues by cross-functional collaboration.
* Ability to operate in a matrix organization and navigate regulations, standards, and performance requirements.
* Knowledge of reliability tools and practices supporting requirements, design, integration, verification, and validation.
* Demonstrated critical thinking with focus on improved system performance and business impact.
* Excellent communication and influential skills are critical to the role.
Physical Job Requirements
Medtronic offers a competitive salary and flexible benefits package. This description reflects the general nature and level of work and is not an exhaustive list of responsibilities and skills.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We provide a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and address challenging health problems by finding solutions. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart, committed to solving real problems for real people.
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