Siemens Polarion Lead Product Analyst
13 days ago
Raritan
Job DescriptionJob 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/SAFeJob 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 ManagementDesirable 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