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
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Siemens Polarion
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Requirements Management
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Risk Management and Mitigation
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Requirements Traceability
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Medical Device Product Development
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R&D Requirements and Systems Engineering
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Design Controls
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Verification and Validation (V&V)
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User Stories and Acceptance Criteria
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Product Backlog and Delivery Management
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Regulated Industry Compliance
Secondary Skills
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Polarion Configuration and Administration
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Functional Requirements and System Specifications
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Process Flows and Functional Design
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Quality Management and Regulatory Processes
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Test Management and Traceability Reporting
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Jira and Confluence
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Data Migration and Data Validation
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Dashboards and Reporting
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Agile, Scrum, and SAFe Methodologies
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Cross-Functional Stakeholder Management
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Risk Assessment and Issue Resolution
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Documentation and Knowledge Transfer
Key Responsibilities
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Translate business needs into user stories, system requirements, acceptance criteria, process flows, and functional designs.
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Support Siemens Polarion capabilities for product requirements and risk management.
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Maintain end-to-end traceability across requirements, risks, mitigations, verification, validation, and supporting evidence.
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Partner with R&D, quality, regulatory, systems engineering, and technology teams to clarify requirements and align solutions.
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Manage delivery priorities, backlogs, scope, dependencies, risks, and production issues.
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Identify opportunities to improve requirements management, risk traceability, and delivery efficiency.
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Support the implementation and enhancement of requirements and risk management processes.
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Create functional documentation, process guides, and supporting technical artifacts.
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Facilitate cross-functional discussions to resolve issues and drive decisions.
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Provide knowledge transfer and guidance to internal teams.
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Support Agile delivery practices and ensure alignment between business priorities and technical implementation.
Required Qualifications
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7+ years of experience in product development, requirements management, business analysis, or related technology solutions.
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5+ years of experience in medical devices or another regulated industry.
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Hands-on Siemens Polarion experience supporting requirements, risks, controls, and end-to-end traceability.
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Strong understanding of R&D product development, design controls, verification, and validation.
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Experience working with R&D, quality, regulatory, systems engineering, and technical teams.
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Experience with Agile delivery methodologies and backlog management.
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Strong analytical, communication, facilitation, and problem-solving skills.
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Ability to work independently and deliver results with limited supervision.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
We are committed to providing reasonable accommodations to qualified applicants with disabilities and for sincerely held religious beliefs, as required by applicable law. Applicants who require a reasonable accommodation during the hiring process may request assistance.
Employment may be contingent upon the successful completion of job-related pre-employment screening, which may include background and reference checks and, where permitted by applicable law and applicable to the position, drug testing. All such screening will be conducted in accordance with applicable federal, state, and local laws.
