Note: The job is a remote job and is open to candidates in USA. VOLTO Consulting is seeking a contract Lead Product Analyst to support MedTech R&D requirements and risk management, primarily using Siemens Polarion. The role translates business needs into requirements and scalable solutions while maintaining traceability and partnering with R&D, quality, regulatory, systems engineering, and technology teams.

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 traceability across requirements, risks, mitigations, verification, validation, and supporting evidence
• Facilitate cross-functional discussions to clarify requirements, resolve issues, and align on solutions
• Manage delivery priorities, backlogs, scope, dependencies, risks, and production issues
• Identify opportunities to improve processes, traceability, and delivery efficiency
• Create documentation and provide knowledge transfer to internal teams

Skills

• Seven or more years of experience in product development, requirements management, or related technology solutions
• Five or more years of experience in the medical device 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 partnering with R&D, quality, regulatory, systems engineering, and technical teams
• Experience with Agile delivery methods and backlog management
• Strong communication, facilitation, analytical, and problem-solving skills
• Ability to work independently and deliver results with limited oversight
• Experience configuring Siemens Polarion in a regulated environment
• Experience aligning Polarion with quality, test management, regulatory, or engineering systems
• Experience with Jira, Confluence, data migration, dashboards, or traceability reporting
• SAFe certification or similar Agile experience

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