Siemens Polarion Lead Product Analyst

Location: Raritan, NJ
Contract: 6 Months
Experience Required: 7+ Years
Job Description

We are seeking an experienced Lead Product Analyst to support MedTech R&D requirements and risk management capabilities, with a primary focus on Siemens Polarion. The ideal candidate will have strong expertise in requirements management, product development, risk management, and end-to-end traceability within regulated environments.

The role involves partnering with R&D, quality, regulatory, systems engineering, and technology teams to translate business requirements into scalable solutions. The candidate will manage requirements, support risk and control traceability, coordinate cross-functional delivery, and improve processes across the product development lifecycle.

Primary Skills

• Siemens Polarion

• Requirements Management

• Risk Management and Mitigation

• Requirements Traceability

• Medical Device Product Development

• R&D Requirements and Systems Engineering

• Design Controls

• Verification and Validation (V&V)

• User Stories and Acceptance Criteria

• Product Backlog and Delivery Management

• Regulated Industry Compliance

Secondary Skills

• Polarion Configuration and Administration

• Functional Requirements and System Specifications

• Process Flows and Functional Design

• Quality Management and Regulatory Processes

• Test Management and Traceability Reporting

• Jira and Confluence

• Data Migration and Data Validation

• Dashboards and Reporting

• Agile, Scrum, and SAFe Methodologies

• Cross-Functional Stakeholder Management

• Risk Assessment and Issue Resolution

• Documentation and Knowledge Transfer

Key Responsibilities

• Translate business needs into user stories, system requirements, acceptance criteria, process flows, and functional designs.

• Support Siemens Polarion capabilities for product requirements and risk management.

• Maintain end-to-end traceability across requirements, risks, mitigations, verification, validation, and supporting evidence.

• Partner with R&D, quality, regulatory, systems engineering, and technology teams to clarify requirements and align solutions.

• Manage delivery priorities, backlogs, scope, dependencies, risks, and production issues.

• Identify opportunities to improve requirements management, risk traceability, and delivery efficiency.

• Support the implementation and enhancement of requirements and risk management processes.

• Create functional documentation, process guides, and supporting technical artifacts.

• Facilitate cross-functional discussions to resolve issues and drive decisions.

• Provide knowledge transfer and guidance to internal teams.

• Support Agile delivery practices and ensure alignment between business priorities and technical implementation.

Required Qualifications

• 7+ years of experience in product development, requirements management, business analysis, or related technology solutions.

• 5+ years of experience in medical devices or another regulated industry.

• Hands-on Siemens Polarion experience supporting requirements, risks, controls, and end-to-end traceability.

• Strong understanding of R&D product development, design controls, verification, and validation.

• Experience working with R&D, quality, regulatory, systems engineering, and technical teams.

• Experience with Agile delivery methodologies and backlog management.

• Strong analytical, communication, facilitation, and problem-solving skills.

• Ability to work independently and deliver results with limited supervision.