DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries about this opportunity, please contact our Talent Specialist, Hema Malini at .
Title: Systems Design Engineer 4
Duration: 12 Months
Location: San Diego, CA (Although highly prefer Onsite / hybrid in San Diego, aligned to Pacific Time and able to collaborate across time zones.)
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Job Description:
- 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.
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.
Work related years of experience: 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.
Education Requirements: Bachelor's degree in Systems Engineering, Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, or a related technical discipline. Master's degree preferred. Equivalent relevant experience may be considered consistent with Dexcom contingent-worker requirements.
Required Testing: No pre-employment technical test currently specified. Interview panel will assess requirements-writing quality, decomposition, interfaces/data flows, traceability, architecture reasoning, risk integration, and ability to resolve an ambiguous software-app scenario.
Software Skills Required: Jama Connect; Jira; Confluence; GitHub; TestRail or equivalent verification tool; Microsoft Office. Ability to interpret API/interface documentation, software architecture views, data flows, and Agile development artifacts.
Required Certifications: None required. INCOSE CSEP is preferred; relevant medical-device software or Agile certifications are beneficial.
About us:
DivIHN, the ''IT Asset Performance Services'' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
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