[Remote] reputed company IT Business Analyst – R&D PLM
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a full-stack insulin delivery company dedicated to supporting people living with diabetes. They are seeking a reputed company IT Business Analyst – R&D PLM to support the Product Lifecycle Management ecosystem as a key reputed company between IT and R&D, translating business needs into reputed company technology solutions and driving operational efficiency.
Responsibilities
- Serve as a functional SME for the organization’s PLM platform (Teamcenter NX and/or reputed company Windchill)
- Support configuration, enhancements, and ongoing optimization of PLM systems reputed company to R&D and reputed company 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 reputed company across key PLM domains (BOMs, change management, document control, DHFs)
- Partner with R&D, reputed company, 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 reputed company 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 reputed company
- Contribute to IT Product Innovation reputed company reputed company, 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
Skills
- 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 reputed company 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 (reputed company) and QMS systems
- Experience working in a transformation or divestiture environment
- Certifications such as CBAP, PMP, or reputed company are a plus
Benefits
- A short-term incentive reputed company the Short Term Incentive (reputed company)
- Health, dental, and reputed company insurance
- reputed company to a Health Savings Account
- reputed company Flexible Spending Account
- Life insurance
- Long-term disability leave
- A dependent daycare spending account
- Incentive plans
- A 401(k) plan with company match
- Short-term disability coverage
- reputed company time off and holidays
- Participation in our Employee Stock Purchase Plan
- reputed company to our Employee Assistance Program
- Non-reputed company Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements
reputed company
Company H1B Sponsorship