Systems Design Engineer 4

Title: Systems Design Engineer 4 / Software ApplicationsLocation: San Diego, CA / Remote Pacific TimeDuration: 12 monthsJob 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.”