We are seeking an experienced Contract Lead Product Analyst to support MedTech R&D requirements and risk management capabilities, with a primary focus on Siemens Polarion.
\nThe contractor will partner with R&D, quality, regulatory, systems engineering, and technology teams to translate business needs into clear requirements and scalable solutions. This role requires strong knowledge of regulated product development, requirements traceability, and risk management.
\n \nKey Responsibilities:
\n• Translate business needs into user stories, system requirements, acceptance criteria, process flows, and functional designs.
\n• Support Siemens Polarion capabilities for product requirements and risk management.
\n• Maintain traceability across requirements, risks, mitigations, verification, validation, and supporting evidence.
\n• Facilitate cross-functional discussions to clarify requirements, resolve issues, and align on solutions.
\n• Manage delivery priorities, backlogs, scope, dependencies, risks, and production issues.
\n• Identify opportunities to improve processes, traceability, and delivery efficiency.
\n• Create documentation and provide knowledge transfer to internal teams.
\nRequired Qualifications
\n• Seven or more years of experience in product development, requirements management, or related technology solutions.
\n• Five or more years of experience in the medical device or another regulated industry.
\n• Hands-on Siemens Polarion experience supporting requirements, risks, controls, and end-to-end traceability.
\n• Strong understanding of R&D product development, design controls, verification, and validation.
\n• Experience partnering with R&D, quality, regulatory, systems engineering, and technical teams.
\n• Experience with Agile delivery methods and backlog management.
\n• Strong communication, facilitation, analytical, and problem-solving skills.
\n• Ability to work independently and deliver results with limited oversight.
\nPreferred Qualifications
\n• Experience configuring Siemens Polarion in a regulated environment.
\n• Experience aligning Polarion with quality, test management, regulatory, or engineering systems.
\n• Experience with Jira, Confluence, data migration, dashboards, or traceability reporting.
\n• SAFe certification or similar Agile experience.
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