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 LifeMedtronicAt Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.Our Purpose In Medtronic SH and A pre-market group, our purpose is to strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.Come for a job, stay for a career!A Day in The Life Of: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 minimum 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 focus on improved system performance outcomes and positive business impact. Excellent communication and ability to influence is critical to the role.Medtronic offer a competitive salary and flexible Benefits Package#IJAPhysical Job RequirementsThe 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. Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity here