Title: Systems Design Engineer 4 / Software Applications Location: San Diego, CA / Remote Pacific Time Duration: 12 months
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.
What you have:
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.
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.
Regulated medical device, digital health, SaMD, IEC 62304, design controls, and ISO 14971 experience is preferred.
Mobile iOS/Android, REST APIs, SDKs, cloud/microservices, data platforms, BLE/connectivity, cybersecurity, or partner-integration experience is preferred.
INCOSE CSEP, SysML/MBSE, and AI-assisted requirements, traceability, or architecture-analysis experience is preferred.
Important Screening Criteria:
This is a Staff-level Systems Engineering role focused heavily on software applications, not a traditional Project Manager, Program Manager, Business Analyst, QA/Test, or documentation role.
Candidate must have direct hands-on experience authoring system/software requirements, not just coordinating requirements or managing user stories.
Strong experience with front-end/mobile applications and backend/API/cloud services is required.
Candidate should have experience with requirements decomposition, architecture/interfaces, data flows, and end-to-end traceability.
Jama Connect experience is strongly preferred; equivalent requirements-management platforms may be considered.
Medical device, digital health, SaMD, IEC 62304, design controls, and ISO 14971 experience is highly preferred.
Disqualifiers/Dislikes on Resumes:
Disqualify if the resume shows only project/program management, business analysis, user-story coordination, software testing, or documentation support without direct requirements authorship.
Disqualify candidates with no mobile/backend/API/cloud experience.
Disqualify candidates with no traceability ownership.
Disqualify candidates whose experience is primarily hardware/embedded without application-software depth.
Software Skills:
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. Certifications:
None required. INCOSE CSEP is preferred; relevant medical-device software or Agile certifications are beneficial.
Work Location:
Remote Pacific timezone; although highly preferred onsite/hybrid in San Diego, aligned to Pacific Time and able to collaborate across time zones.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Numbers & Facts
Location
San Diego, CA (Remote)
Salary
$71.27–$75.87 Per Hour
Skills
Agile Programming Methodologiesunmatched
Androidunmatched
Application Programming Interface (API)unmatched
Architectural Analysisunmatched
Architectural Designunmatched
Artificial Intelligence (AI)unmatched
Business Analysisunmatched
Clinical Dataunmatched
Cloud Applicationsunmatched
Cloud Computingunmatched
Cross-Functionalunmatched
Documentationunmatched
Gap Analysisunmatched
Hazard Analysisunmatched
Healthcare Softwareunmatched
Human Factorsunmatched
ISO (International Organization for Standardization)unmatched
International Electro-Technical Commission (IEC)unmatched
Internet Securityunmatched
Medical Equipmentunmatched
Mentoringunmatched
Microservicesunmatched
Product Lifecycleunmatched
Product Managementunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
REST (Representational State Transfer)unmatched
Regulationsunmatched
Requirements Managementunmatched
Risk Analysisunmatched
Risk Managementunmatched
Software Engineeringunmatched
Software Testingunmatched
Support Documentationunmatched
System Architectureunmatched
Systems Analysisunmatched
Systems Engineeringunmatched
Team Playerunmatched
Technical Leadershipunmatched
Technical/Engineering Designunmatched
Testingunmatched
Traceabilityunmatched
Verification Plansunmatched
iOSunmatched
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