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Niche regulated medical-device software requirements role requiring 10+ years and DOORS reduces applicant pool.
Requires medical-device regulatory and requirements engineering expertise, limiting cross-industry transferability.
Explicit 10+ years, regulated medical-device experience and mandatory requirements tool expertise increase filtering.
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Own and author clear, testable software requirements for medical device products in the ENT, Plastic & Refractive portfolio, ensuring regulatory compliance and traceability throughout the product lifecycle.
Manage and prioritize the product backlog aligned with product roadmap and program milestones, decomposing requirements into features, epics, and user stories with acceptance criteria.
Collaborate closely with global cross-functional teams including Software Development, QA, Product Management, Systems Engineering, Regulatory, and Quality to support design reviews, risk assessments, and validation activities.
10+ years of experience in software development within the medical device industry and regulated environments.
Proven hands-on experience with requirements engineering and ownership of software requirements documentation (e.g., SRS, SWRS).
Strong knowledge of regulated software development lifecycles and experience with requirements management tools such as DOORS, Polarion, or Codebeamer.
Work Experience Required: 10+ years in relevant domain. No mention of mandatory degree or location constraints in JD.
Experienced in operating within regulated medical device software development environments with structured processes and design controls.
Comfortable collaborating with global cross-functional teams including regulatory and quality functions to ensure alignment and compliance.
Capable of managing detailed, traceable requirements and balancing Agile methodologies with strict regulatory compliance demands.