Medtronic Senior Reliability Engineer in Galway, Ireland
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Works closely with Research & Development in the development of Test methods to ensure that they are ready 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.
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.
Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
You will lead strategies for test method validations, design verification, and shelf-life protocols/reports.
Key Skills & Experience
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 with a minimum of 4 years’ 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 a focus on improved system performance outcomes and positive business impact.
Excellent communication and ability to influence is critical to the role.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.
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