Senior Software Quality Engineer – CST – Lafayette, CO (Onsite)

We anticipate the application window for this opening will close on - 26 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world. Medtronic Cranial & Spinal Technologies (CST) empowers surgeons with connected technologies that improve precision, efficiency, and outcomes in complex spine and cranial procedures. This role supports AiBLE within the Cranial & Spinal Technologies Operating Unit. AiBLE combines artificial intelligence, machine learning, and advanced digital technologies to enhance surgical planning, navigation, workflow efficiency, and clinical decision-making across the CST portfolio. This position is based in Lafayette, Colorado and is expected to work onsite. Travel requirements are less than 10%. Check us out on LinkedIn: Medtronic CST As a Senior Software Design Quality Engineer, you will support the entire software development lifecycle (SDLC) of the AiBLE portfolio, ensuring software products meet quality, performance, and regulatory requirements from development through commercialization. Working closely with software, systems, and quality teams, you will drive quality throughout the product lifecycle by supporting verification and validation activities, ensuring compliance with design control requirements, and contributing to continuous improvement initiatives. Primary Responsibilities Lead software quality engineering activities throughout the software development lifecycle, including requirements, design, development, integration, testing, release, and validation. Support the AiBLE portfolio by ensuring software products comply with quality system, regulatory, and product development requirements. Drive software verification and validation activities, ensuring traceability, test coverage, and alignment to system and software requirements. Review software architecture, design documentation, risk management documentation, and engineering changes to assess compliance with quality and regulatory expectations. Develop and maintain software quality processes, procedures, and standards to support compliant product development and commercialization. Analyze and monitor quality metrics to identify trends, assess product performance, and support continuous improvement efforts. Ensure design history files, validation records, and other project documentation meet quality standards and audit requirements. Partner with cross-functional teams to investigate, resolve, and prevent software quality issues throughout product development and post-market activities. Required Qualifications Bachelor’s degree in Engineering, Computer Science, Software Engineering, or a technical discipline and 4+ years of Software Quality Engineering experience; OR Master’s degree and 2+ years of Software Quality Engineering experience OR PhD and 0+ years of Software Quality Engineering experience. Experience supporting software verification and validation activities within a product development environment. Knowledge of software development lifecycle processes, software quality systems, and design control requirements. Experience reviewing technical documentation, requirements, test evidence, risk assessments, and change controls. Ability to effectively collaborate with cross-functional stakeholders to support product quality and compliance objectives. Preferred Qualifications Experience in the medical device industry or another regulated industry with software quality requirements. Knowledge of U.S. Food and Drug Administration regulations, IEC 62304, ISO 13485, and software development quality standards. Experience with artificial intelligence-enabled software, Software as a Medical Device (SaMD), digital health technologies, or embedded software. Experience with test automation tools, scripting languages such as Python, C++, or MATLAB, and data-driven testing approaches. Knowledge of risk management principles, ISO 14971, design controls, and regulatory submission support activities. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. 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. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.