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Niche medical-device systems engineering role with senior requirements reduces applicant competition.
Strong medical-device regulatory and systems focus limits cross-industry transferability.
Explicit 8+ years, medical-device compliance, and mandatory tools like Jama and IEC/ISO standards increase screening strictness.
Translate high-level product vision, user needs, and UI/UX designs into detailed, testable technical requirements for medical devices and related mobile applications (Android and iOS).
Lead requirements traceability, manage system engineering documentation using tools like Jama Connect, and oversee thorough reviews to ensure completeness and consistency.
Advocate and mentor on system engineering best practices, including strategic use of GenAI tools to enhance documentation quality and efficiency.
Bachelor’s degree in engineering or advanced degree.
At least 8 years related experience (Bachelor’s) or 5+ years (advanced degree).
Proficiency with systems engineering and requirement management tools like Jama Connect.
Experience with medical device development, mobile app development (Android/iOS), and relevant industry standards (IEC 62304, ISO 14971).
Experienced in bridging multi-disciplinary engineering teams and maintaining end-to-end requirements traceability in regulated medical device projects.
Skilled user and mentor of generative AI tools to enhance systems engineering workstreams and documentation efficiency.
Demonstrated ability to lead complex systems engineering initiatives from concept through commercialization with strong communication across technical and non-technical stakeholders.