Staff Software Systems Engineer - Regulated Traceability

Eliassen Group

United States

Remote

Confidential

Full time

14 days+

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Job summary

Eliassen Group is seeking a Staff Software Systems Engineer to lead software requirements engineering, traceability, and software risk analysis for software-intensive products across mobile apps, web apps, APIs, SDKs, cloud services, and connected workflows.

The role translates product, user, clinical, regulatory, cybersecurity, and operational needs into clear, feasible system and software requirements, ensuring end-to-end traceability in Jama Connect or equivalent within a regulated

Qualifications

8+ years in Systems Engineering or requirements engineering for software-intensive products, including direct authorship for mobile/front-end and backend/API/cloud services.
Demonstrated staff-level ownership of architecture decomposition, interfaces, workflows, ambiguity resolution, and cross-functional technical leadership.
Hands-on requirements management and end-to-end traceability using Jama Connect or equivalent (DOORS, Polarion, CodeBeamer), including linkage to design, risk controls, and verification evidence.
Experience with iOS, Android, watch, and web applications preferred, plus understanding of APIs, SDKs, cloud, backend services, and platforms.
Strong systems thinking, communication, and collaboration skills across product, engineering, test, regulatory, and quality teams.
Preferred experience with regulated environments such as medical devices, digital health, SaMD, and familiarity with IEC 62304 and ISO 14971.
Familiarity with Jira, Confluence, risk management tools, verification tools, GitHub, and Agile artifacts.

Responsibilities

Author, review, baseline, and maintain high-quality System and Software Requirements Specifications in Jama Connect with strong decomposition, allocation, and change control.
Decompose system requirements into software requirements and define acceptance criteria with Product and Engineering.
Establish and maintain end-to-end traceability across user needs, system and software requirements, design outputs, risk controls, and verification evidence. Perform gap and impact analyses.
Lead feature- and subsystem-level Systems Engineering activities across iOS/Android, web, backend services, APIs, SDKs, cloud services, and connected workflows.
Develop and maintain interface requirements, data-flow definitions, workflows, operational concepts, and API/integration specifications across device, app, cloud, backend, data platform, and partner boundaries.
Partner with Product Management, Software Engineering, Architecture, Verification, Quality, Regulatory, Human Factors, Cybersecurity, Clinical, Data Platform, and partner-integration teams throughout the lifecycle.
Contribute to system hazard analysis, software risk assessment, and interface-risk evaluation. Define and trace risk-control requirements consistent with ISO 14971 principles.
Support verification planning, acceptance-criteria development, defect and field-issue investigations, sustaining changes, and release impact assessments.
Drive technical reviews, resolve ambiguity, document assumptions and decisions, and align stakeholders without direct authority.
Mentor engineers on requirements quality, traceability, interfaces, architecture thinking, and regulated Systems Engineering practices.