Remote Staff Systems Engineer — Regulated Software & API

Eliassen Group; Salem (OR); On-site; USD 85,000 - 99,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group is seeking a Staff Software Systems Engineer to lead software requirements engineering across mobile, web, backend, APIs, and cloud services. You will drive cross-functional alignment, maintain end-to-end traceability, and ensure regulatory compliance in a regulated environment.

The role emphasizes strong decompositions, interface definitions, and risk analysis, with collaboration across Product, Architecture, Verification, Quality, Cybersecurity, and Clinical teams.

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.
• 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).
• 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.

Skills

Systems engineering

Requirements engineering

Traceability

Regulated environments

Education

Bachelor's degree

Master's degree

Tools

Jama Connect

DOORS

Polarion

CodeBeamer

Jira

Confluence

GitHub

Job description

Eliassen Group is seeking a Staff Software Systems Engineer to lead software requirements engineering across mobile, web, backend, APIs, and cloud services. You will drive cross-functional alignment, maintain end-to-end traceability, and ensure regulatory compliance in a regulated environment.

The role emphasizes strong decompositions, interface definitions, and risk analysis, with collaboration across Product, Architecture, Verification, Quality, Cybersecurity, and Clinical teams.