Principal IT Business Analyst – R&D PLM

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes. They are seeking a Principal IT Business Analyst – R&D PLM to support the Product Lifecycle Management ecosystem as a key liaison between IT and R&D, translating business needs into scalable technology solutions and driving operational efficiency.

Responsibilities:

• Serve as a functional SME for the organization’s PLM platform (Teamcenter NX and/or PTC Windchill)
• Support configuration, enhancements, and ongoing optimization of PLM systems aligned to R&D and Quality needs
• Translate R&D and engineering business requirements into effective system solutions
• Partner with technical teams to implement integrations with ERP, QMS, and CAD systems
• Maintain data integrity across key PLM domains (BOMs, change management, document control, DHFs)
• Partner with R&D, Quality, Regulatory, and Engineering teams to understand business needs and processes
• Facilitate requirements gathering sessions and document business and functional specifications
• Support solution design discussions and provide recommendations based on business needs
• Identify process improvement opportunities and contribute to solution enhancements
• Build strong working relationships with cross-functional stakeholders
• Support alignment across teams by facilitating discussions and clarifying requirements
• Communicate effectively with both technical and non-technical audiences
• Escalate risks and issues appropriately while helping drive resolution
• Contribute to IT Product Innovation related projects, supporting planning, execution, and delivery
• Collaborate with vendors, system integrators, and internal IT teams
• Assist with testing coordination, defect tracking, and user acceptance validation
• Support adherence to regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR)
• Assist in audit readiness activities, including documentation and process validation support
• Contribute to CSV activities (IQ/OQ/PQ documentation and execution support) as needed

Requirements:

• 7+ years of experience with a bachelor's degree or 5+ years of experience with an advanced degree or 12+ years of experience with a high school diploma or equivalent
• Bachelor's degree in Computer Science, Information Systems, Engineering, or related field
• 8+ years of IT experience, including 3+ years working with PLM systems (Teamcenter, Windchill, or similar)
• Experience supporting R&D, Engineering, or Product Development teams, ideally in a regulated environment
• Strong understanding of PLM fundamentals (BOMs, change management, document control, workflows)
• Experience gathering and documenting business requirements and working with cross-functional teams
• Solid communication, problem-solving, and organizational skills
• Experience in the medical device or regulated industry
• Familiarity with computer systems validation (CSV) processes
• Exposure to PLM integrations with ERP (SAP) and QMS systems
• Experience working in a transformation or divestiture environment
• Certifications such as CBAP, PMP, or SAFe are a plus