Careers that Change Lives A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people.Help us engineer the extraordinary! Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description. We are currently looking for a Senior Software Quality Engineer to join our Cranial and Spinal Technologies operating unit (CST). This position will be based onsite in Lafayette, Colorado. A Day in the Life In this exciting role as a Senior Software Quality Engineer , you will represent the Design Quality Engineering team, working with cross-functional partners in defining the strategy and roadmap for the test automation and test execution for software new product development projects. Responsibilities may include but are not limited to: Provide Software (SW) risk management technical leadership to Design Quality Engineering peers Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files Provide Risk analysis, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety Define appropriate measures to ensure software quality Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development Identify and implement software process metrics for the software product development lifecycle Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable Must Have: Minimum Requirements Bachelors degree required in Engineering, Science, or a technical field Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have Working knowledge with medical device design controls Working knowledge in software development (IEC 62304) Working knowledge in risk management (ISO 14971) Experience in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle