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