Senior Principal IT Business Analyst - Quality Management Technologies
About The Position
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. 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. 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.
Requirements
- 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 Haves
- 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.
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.
- 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.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
