Business Systems Analyst Medical Device Industry

We are looking for an experienced Business Systems Analyst (BSA) for Siemens Teamcenter and with deep expertise in Application Lifecycle Management (ALM) and Product Lifecycle Management (PLM) to support and enhance enterprise systems within a regulated medical devices environment
. This role will serve as a critical liaison between business stakeholders, quality/regulatory teams, engineering, and IT, with a primary focus on supporting and optimizing the Siemens Teamcenter PLM application and its integrations across the product development lifecycle.

The ideal candidate will bring strong domain knowledge of medical device product development, change management, and compliance, along with hands‑on experience translating business requirements into scalable system solutions.

• Act as a trusted partner to business, engineering, quality, regulatory, and IT stakeholders to understand business needs and system requirements
• Facilitate workshops, interviews, and working sessions to elicit, analyze, and document functional and non-functional requirements
• Translate complex business processes into clear system requirements, user stories, and functional specifications
• Serve as a subject matter expert for ALM and PLM processes across the product lifecycle

• Support end-to-end ALM and PLM processes
  , including requirements management, design controls, change management, configuration management, and product documentation
• Provide functional ownership and support for the Siemens Teamcenter PLM application, including configuration, enhancements, and issue resolution
• Collaborate with technical teams on system upgrades, patches, and new module implementations
• Ensure seamless integration between Teamcenter and related enterprise systems (e.g., ERP, ALM tools, document management systems)

• Ensure system processes and configurations comply with medical device regulatory requirements (e.g., FDA, ISO 13485, IEC 62304, 21 CFR Part 11)
• Support audit readiness by maintaining traceability, documentation, and validated system workflows
• Participate in system validation activities, including requirements traceability, test case review, and validation documentation support

• Work closely with solution architects and development teams to design scalable, compliant solutions
• Review and validate system configurations and customizations against business requirements
• Support user acceptance testing (UAT) by developing test scenarios, coordinating testing activities, and resolving defects
• Assist with data migration, system rollout, and post-implementation support

• Analyze current-state processes and identify opportunities for process optimization and system improvements
• Support change management initiatives, including impact analysis, documentation, and user training support
• Develop and maintain process flows, SOPs, and system documentation
• Monitor system performance and user feedback to drive continuous improvement

• Bachelor’s degree in Information Systems, Engineering, Computer Science, Business Administration, or a related field

• 5+ years of experience as a Business Systems Analyst or similar role
• Strong hands‑on experience with ALM and PLM systems in a regulated industry
• Proven experience supporting Teamcenter PLM (configuration, enhancements, integrations, or functional support)
• Experience working within medical devices, life sciences, or highly regulated environments
• Demonstrated experience gathering and documenting business and system requirements

• Deep understanding of product development lifecycle and design control processes
• Strong knowledge of PLM concepts: BOM management, ECO/ECR, document control, configuration management
• Familiarity with ALM tools and processes (requirements, test management, defect tracking)
• Experience with system integrations, data flows, and enterprise architecture concepts
• Proficiency in creating functional specifications, process diagrams, and traceability matrices

• Experience with system validation (CSV) in regulated environments
• Familiarity with ERP integrations (e.g., SAP, Siemens Teamcenter, Trackwise)
• Experience supporting global teams and multi‑site deployments
• Knowledge of Agile, Scrum, or hybrid SDLC methodologies
• PLM or ALM‑related certifications