Day to Day Responsibilities: • Specialized staff-level Systems Engineering support for front-end and backend software application requirements, architecture decomposition, interfaces, traceability, and risk activities. • Own feature- and subsystem-level Systems Engineering activities for software-intensive products across iOS/Android mobile apps, web applications, backend services, APIs, SDKs, cloud services, and connected CGM workflows. • Translate product, user, clinical, regulatory, cybersecurity, and operational needs into clear, feasible, testable system and software requirements for front-end and backend applications. • Author, review, baseline, and maintain System and Software Requirements Specifications in Jama Connect, applying strong requirement quality, decomposition, allocation, and change-control practices. • Define and maintain end-to-end traceability among user needs, system requirements, software requirements, architecture/design outputs, risk controls, and verification evidence; perform gap and impact analyses. • Develop and maintain interface requirements, data-flow definitions, workflow models, operational concepts, and API/integration specifications across device, app, cloud, backend, data platform, and partner boundaries. • Lead requirements and technical reviews, resolve ambiguity, document assumptions and decisions, and drive cross-functional alignment without direct authority. • Partner with Product Management, Software Engineering, Architecture, Verification, Quality, Regulatory, Human Factors, Cybersecurity, Clinical, Data Platform, and partner-integration teams throughout the development lifecycle. • Contribute to system hazard analysis, software risk assessment, interface-risk evaluation, and definition/traceability of risk-control requirements in accordance with applicable procedures and ISO 14971 principles. • Support verification planning, acceptance-criteria development, defect and field-issue investigations, sustaining changes, and release impact assessments. • Mentor engineers on software requirements quality, traceability, interfaces, architecture thinking, and regulated Systems Engineering practices; deliver complete, review-ready artifacts and status updates. • Bachelor's degree with 8+ years of relevant experience, or Master's degree with 6+ years. Must include substantial hands-on experience in Systems Engineering or requirements engineering for software-intensive products.
Required Skills (top 3 non-negotiables): 8+ years in Systems Engineering/requirements engineering, including direct authorship of system and software requirements for mobile/front-end applications and backend/API/cloud services. Demonstrated staff-level ownership of software feature/subsystem architecture decomposition, interfaces, workflows, ambiguity resolution, and cross-functional technical leadership. Hands-on requirements management and end-to-end traceability using Jama Connect or an equivalent platform, including needs, design, risk controls, and verification evidence.
Preferred Skills (nice to have) Regulated medical device, digital health, SaMD, IEC 62304, design controls, and ISO 14971 experience. Mobile iOS/Android, REST APIs, SDKs, cloud/microservices, data platforms, BLE/connectivity, cybersecurity, or partner-integration experience. INCOSE CSEP, SysML/MBSE, and AI-assisted requirements, traceability, or architecture-analysis experience.
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $75.00/hr - $77.00/hr.
