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Metro location and known employer increase density, but niche regulated medical-device requirement limits generalist competition.
Requires regulated medical-device requirements engineering, limiting cross-industry transferability and favoring domain-experienced candidates.
Explicit 10+ years plus mandated regulated medical-device experience and specific requirements tools increases filter strictness.
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Own and author clear, unambiguous software requirements and manage requirements documentation for medical device software products in the Neuro & Spine portfolio.
Maintain end-to-end traceability from requirements through design, implementation, and verification; manage and prioritize product backlog aligned to roadmap and milestones.
Collaborate with cross-functional global teams including Product Management, Systems Engineering, Regulatory, Quality, and Engineering to ensure compliance with regulatory standards and support verification and validation activities.
10+ years experience in software development for medical devices within regulated environments.
Proven hands-on experience in software requirements engineering and ownership of software requirements documentation (SRS, SWRS, or equivalent).
Experience with requirements management tools such as DOORS, Polarion, or Codebeamer in regulated environments.
Work Experience Required: 10+ years in medical device software development and requirements engineering.
Experienced individual contributor focused on detailed requirements engineering rather than product vision or architecture ownership.
Strong familiarity with regulated software development lifecycles including design controls and risk management in medical device industry.
Effective at managing cross-functional global stakeholder alignment and balancing Agile execution with regulatory compliance.