Principal IT Business Analyst – R&D PLM

Principal IT Business Analyst – R&D PLM About The Role

Mini Med is seeking a Principal IT Business Analyst – R&D PLM to support the Product Lifecycle Management (PLM) ecosystem as a key liaison between IT and R&D. This role focuses on translating business needs into scalable technology solutions, supporting system enhancements, and driving operational efficiency within a complex, matrixed environment.

• 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

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

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…