Staff System Engineer - Hybrid

For further inquiries about this opportunity, please contact our Talent Specialist, Hema Malini at View phone number on us.fitly.work or Justeen at View phone number on us.fitly.work.

Title: Staff System Engineer - Hybrid
Duration: 12 Months
Location: Remote

Schedule: Preference for 3 days hybrid in San Diego. For remote candidates, MST/CST preferred.

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description:

Experienced Systems Engineer with strong expertise in software-intensive systems, requirements engineering, architecture decomposition, interfaces, traceability, and risk management. Demonstrated ability to translate product, user, operational, and regulatory needs into high-quality system and software requirements for mobile applications, web applications, backend services, APIs, cloud platforms, and connected device ecosystems. Effective at driving technical alignment across cross-functional teams and operating independently in complex product development environments. The target profile aligns with Staff-level expectations of architecture ownership, ambiguity reduction, technical leadership, and cross-functional influence.

Role Summary

• Software-focused Systems Engineering role supporting medical device products.
• Focus on translating user needs to software requirements while following design controls and regulatory expectations.
• Primary ownership of software features and software-centric systems engineering deliverables.
• 8 10+ years relevant experience; Master's + 6+ years acceptable.
• STEM preferred; Systems Engineering strongly preferred, Biomedical Engineering also suitable.

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.
• Write Software Requirements Specifications (SRS).
• Trace requirements upstream to system-level requirements.
• Trace requirements downstream to software design specifications.
• Participate in software risk analysis.
• Develop software-focused system engineering documentation/deliverables.
• Translate high-level user needs into system/software requirements.
• Understand feature dependencies, system interactions, and cross-functional impacts.

Top 3 Non-Negotiables

Software Requirements Engineering

• Minimum 8+ years of experience developing, authoring, reviewing, and maintaining system and software requirements.
• Must have direct hands-on experience writing requirements for mobile applications, web applications, backend services, APIs, SDKs, or cloud platforms.
• Must be able to decompose product needs into detailed, testable, traceable software requirements.
• 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.

Requirements Traceability and Jama Expertise

• Demonstrated experience using Jama Connect (preferred) or an equivalent requirements management platform.
• Must have owned end-to-end traceability between user needs, system requirements, software requirements, risk controls, and verification evidence.
• Strong experience performing impact assessments, change analysis, and requirements governance.

Software Systems Architecture and Cross-Functional Leadership

• Experience working across mobile apps, cloud services, APIs, backend systems, data flows, and integrations.
• Ability to define interfaces, workflows, operational concepts, and architecture decompositions.
• Must have demonstrated technical leadership driving alignment among Product Management, Software Engineering, QA, RA, Cybersecurity, and other stakeholders without direct authority.

Preferred Skills

• 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.
• Medical device, digital health, SaMD, or other regulated industry experience.
• ISO 14971 risk management experience.
• Experience with iOS/Android application ecosystems.
• REST APIs, cloud services, microservices, and distributed architectures.
• INCOSE CSEP certification.
• AI-assisted requirements engineering and traceability experience.

Technical/Domain Experience

• Preferred: iOS, Android, Web, Watch/Wearable applications.
• Exposure to front-end, back-end services/features, SDKs, APIs, and cloud services.
• Initial work may focus on front-end, eventually evolving to an equal front-end/back-end mix.
• Strong software requirements engineering experience is key.

Requirements Management / Tools

• Jama Connect highly preferred; expected to be used 90 100% of the time.
• Equivalent tools accepted: DOORS, Polarion.
• Candidates with similar tools should be able to learn Jama within a few weeks.
• JIRA familiarity expected.
• Significant documentation generation involved.

Risk & Regulatory

• Risk Management experience expected.
• Medical device experience preferred but not mandatory.
• Preferred standards: ISO 14971, IEC 62304, and Medical Device Quality Management Systems.
• Non-medical candidates can be considered but may require additional ramp-up on medical device regulations/QMS.
• Finance/consumer-product backgrounds may need more regulatory ramp-up.

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.

Interview Process: 2 Rounds

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.