Principal Reliability Engineer

4 days ago

Galway, Galway, Ireland Medtronic Full time
Overview

Principal Reliability Engineer - Cardiac Ablation Solutions at Medtronic. This role is within Cardiac Ablation Solutions (CAS), supporting the development of next generation medical technologies to treat abnormal heart rhythms. The position will be on-site (minimum 4 days per week) based out of Parkmore, Galway, Ireland.

Responsibilities
  • Works closely with Research & Development in the development of test methods to ensure readiness for the Test Method Validation (TMV) process.
  • Ensures all TMVs are validated to meet the required TMV procedures and standards.
  • Collaborates with the quality core team to deliver 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 analyses against features, requirements, architecture, interfaces, and designs using 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.
Qualifications & Experience
  • Advanced knowledge of the job area, combining breadth and depth, typically from advanced education and experience.
  • Minimum Level 8 Degree in Engineering or a relevant discipline with at least 7 years of relevant experience, or an advanced degree with at least 5 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 through cross-functional collaboration.
  • Ability to operate in a matrix organization and navigate complex 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 influencing skills are critical to the role.
Job Details
  • Seniority level: Mid-Senior level
  • Employment type: Full-time
  • Job function: Engineering and Information Technology
  • Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing

Benefits, compensation, and other information are provided by Medtronic as part of the role.


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