Senior Principal IT Business Analyst - Quality Management Technologies

Job description

We anticipate the application window for this opening will close on - 17 Jul 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 LifeAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working onsite 4 days a week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The person in this role will work from the Medtronic facility located in Mounds View, Minnesota. As a Senior Principal IT Business Analyst focused on Quality Management Technologies, you will serve as a senior leader and subject matter expert driving the evolution of Medtronic's enterprise Quality Management System (QMS) primarily on, but not limited to, the TrackWise Digital (Salesforce) platform. You will partner with Quality, Regulatory, Manufacturing, and IT stakeholders to translate complex business needs into scalable, compliant digital solutions that support patient safety and regulatory excellence across Medtronic's global operations. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. Our unwavering commitment to inclusion, diversity, and equity (ID&E) means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communications to achieve long-term sustainable impact. Anchored in our Mission, we continue to drive ID&E forward both to enhance the well-being of Medtronic employees and to accelerate innovation that brings our lifesaving technologies to more people in more places around the world. Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to be a part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We encourage and support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. Join us for a career in IT that changes lives. CAREERS THAT CHANGE LIVES CORE BUSINESS ANALYST RESPONSIBILITIES Engage with business leaders to understand how strategies and data-driven changes can improve efficiencies and add value. Work with data sets to define use cases to improve products, processes, and/or services. Collaborate with Business Relationship Manager (BRM), business stakeholders, and IT Product Owners / Managers to develop business requirements for product or system changes. Drive business agenda during the solution delivery process. QUALITY MANAGEMENT TECHNOLOGIES (TRACKWISE DIGITAL/SALESFORCE) RESPONSIBILITIES Lead end-to-end business analysis for TrackWise Digital solutions supporting Medtronic's global Quality Management System, including CAPA, NCR, Complaints, Audit, Change Control, and Document Management processes. Serve as the platform SME for TrackWise Digital and the underlying Salesforce ecosystem, advising on out-of-the-box capabilities, configuration vs. customization trade-offs, and integration patterns. Drive digital transformation and continuous improvement initiatives within Quality, leveraging Salesforce platform features (Flows, Lightning, Experience Cloud, Einstein Analytics) alongside TrackWise Digital modules. Facilitate cross-functional workshops, story mapping sessions, and design reviews with global stakeholders across Operating Units. Ensure solutions meet GxP, FDA 21 CFR Part 11, ISO 13485, EU MDR, and other regulatory and compliance requirements applicable to medical device QMS. Lead and support Computer System Validation (CSV) activities, including authoring/reviewing URS, FRS, IQ/OQ/PQ, traceability matrices, and validation summary reports. Collaborate with system integrators, Sparta Systems / Honeywell, and internal architects to ensure scalable, sustainable solution delivery. Drive testing strategy, UAT coordination, defect triage, hypercare, and user adoption activities for QMS releases. Mentor junior and mid-level Business Analysts; contribute to BA practice maturity, standards, and knowledge sharing across the IT organization. Travel may be required to Medtronic sites to enhance collaboration and ensure successful project execution. MUST HAVE (Minimum Qualifications) High school diploma (or equivalent) and 12+ years of experience OR Bachelor’s degree and 10+ years of experience or advanced degree and 8+ years of experience NICE TO HAVE (Preferred Qualifications) Previous Medtronic experience (strongly preferred) Hands-on experience implementing or supporting TrackWise Digital (Sparta Systems / Honeywell) on the Salesforce platform Strong understanding of Quality Management System processes (CAPA, NCMR, Complaints, Audit, Change Control, Document Control) within a medical device, pharma, or other highly regulated industry Salesforce platform expertise; Salesforce Administrator, Business Analyst, or Platform App Builder certifications Experience with regulated systems and Computer System Validation (CSV) in an FDA / ISO 13485 / EU MDR environment Demonstrated ability to lead requirements gathering, business process mapping, and solution design for enterprise QMS programs Experience integrating QMS with adjacent systems such as SAP, PLM (Windchill/Agile), MES, and LMS Agile/Scrum delivery experience; familiarity with tools such as Jira, Confluence, and Azure DevOps Excellent communication, facilitation, executive presentation, and stakeholder management skills Project leadership, team lead, or formal mentorship experience 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