Staff Software Systems Engineer

Our client seeks a Staff Software Systems Engineer to lead software requirements engineering, traceability, and software risk analysis for software-intensive products. The role will translate product, user, clinical, regulatory, cybersecurity, and operational needs into clear, feasible, and testable system and software requirements across mobile applications, web applications, backend services, APIs, SDKs, cloud services, and connected workflows. The engineer will drive cross-functional alignment, challenge assumptions, surface risks and dependencies, and maintain end-to-end traceability in Jama Connect or equivalent tools within a regulated environment., * 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.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance., * 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.

Education Requirements:

• Bachelor’s degree strongly expected in Systems Engineering, Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or a related discipline. Master’s degree preferred.

Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.

If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:

· When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients’ capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.