Job Description: Siemens Polarion Lead Product Analyst

• Location: Raritan, NJ
• Duration: 6 Months (Contract)
• Role: Siemens Polarion Lead Product Analyst
• Experience Required: 8–10 Years
• Essential Skills: Siemens Polarion, Requirements Management, Risk Management, PLM, Medical Device R&D
• Desirable Skills: Windchill PLM, Data Migration, Jira, Confluence, Agile/SAFe

Job Summary

• Seeking an experienced Siemens Polarion Lead Product Analyst to support MedTech R&D requirements management, risk management, and product development processes in a regulated environment.
• Partner with R&D, Quality, Regulatory, Systems Engineering, and IT teams to translate business needs into functional requirements and scalable technology solutions.
• Lead requirements definition, risk management, end-to-end traceability, and process improvement initiatives using Siemens Polarion.
• Support alignment between requirements, design controls, risk mitigations, verification, validation, and regulatory compliance throughout the product development lifecycle.

Key Responsibilities

• Lead business requirements gathering, analysis, and documentation, including user stories, system requirements, acceptance criteria, process flows, and functional specifications.
• Support and optimize Siemens Polarion capabilities for requirements management, risk management, and product lifecycle processes.
• Establish and maintain end-to-end traceability across product requirements, risks, controls, mitigations, verification, validation, and supporting evidence.
• Collaborate with R&D, Quality, Regulatory, Systems Engineering, and technical teams to define requirements and align on functional solutions.
• Manage product backlogs, delivery priorities, scope, dependencies, risks, and production issues.
• Support requirements lifecycle management, design controls, and verification and validation activities in compliance with medical device industry standards.
• Analyze existing business processes and identify opportunities to improve requirements traceability, risk management, and delivery efficiency.
• Facilitate cross-functional workshops, stakeholder discussions, and solution reviews to resolve issues and ensure alignment.
• Support Siemens Polarion configuration, workflows, dashboards, reporting, and integration with other engineering and quality systems.
• Coordinate data migration, data mapping, data validation, and traceability reporting activities when integrating or transitioning requirements data.
• Prepare functional documentation, process guidelines, training materials, and knowledge transfer documentation for internal teams.
• Serve as a bridge between business stakeholders, functional analysts, engineering teams, and IT delivery teams.

Required Qualifications

• 8–10 years of overall experience in product analysis, requirements management, systems engineering, or related technology solutions.
• Strong hands-on experience with Siemens Polarion for requirements management, risk management, and end-to-end traceability.
• 5+ years of experience in medical devices, MedTech, life sciences, or another regulated industry.
• Strong understanding of R&D product development processes, design controls, verification, validation, and risk management.
• Experience translating business requirements into functional specifications, user stories, acceptance criteria, and system requirements.
• Experience working with cross-functional teams, including R&D, Quality, Regulatory, Systems Engineering, and IT.
• Knowledge of requirements lifecycle management, change management, traceability, and compliance documentation.
• Experience with Agile methodologies, backlog management, prioritization, and delivery planning.
• Strong analytical, problem-solving, communication, stakeholder management, and facilitation skills.
• Ability to work independently, manage competing priorities, and deliver results with minimal supervision.

Preferred Qualifications

• Experience configuring and administering Siemens Polarion in a regulated product development environment.
• Experience integrating Polarion with quality management, test management, regulatory, engineering, or PLM systems.
• Knowledge of PTC Windchill PLM, including functional workflows, data models, and engineering change management.
• Exposure to PLM data migration, including data extraction, transformation, loading, source-to-target mapping, and data reconciliation.
• Experience with migration utilities, SQL scripts, APIs, or scripting for data transformation and validation.
• Experience with Jira, Confluence, dashboards, reporting, and traceability analytics.
• Knowledge of medical device regulatory requirements and design control practices.
• SAFe certification or equivalent Agile training is preferred.
• Relevant certifications in requirements management, Agile delivery, PLM, or product lifecycle management are advantageous.

Essential Skills

• Siemens Polarion Requirements and Risk Management
• Requirements Lifecycle Management and Traceability
• Medical Device R&D and Design Controls
• Risk Analysis, Mitigation, Verification, and Validation
• Functional and Business Requirements Analysis
• Cross-Functional Stakeholder Management
• Agile Delivery and Backlog Management

Desirable Skills

• PTC Windchill PLM Functional and Technical Knowledge
• PLM Data Migration and Data Validation
• Polarion Configuration and System Integration
• SQL, APIs, and Scripting
• Jira and Confluence
• Traceability Reporting and Dashboards
• Data Mapping and Process Improvement