Staff Software Systems Engineer
Anywhere
Category: Architecture
Industry: Life Sciences
Workplace Type: Remote
Reference ID: JN -082026-108350
Date Posted: 08/19/2026
Shortcut: http://careers.eliassen.com/74UQbR
Description:
Remote
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.
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.
Rate: $62.00 to $72.00/hr. w2
JN -082026-108350
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.
Experience Requirements:
- 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 will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact fraud@eliassen.com.
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Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. Eliassen Group’s Affirmative Action Plan (AAP) is available for inspection by any employee or applicant for employment upon request, during normal business hours of Monday through Friday, 8:30am to 5:30pm EST. Interested persons should contact Phaedra Wells at pwells@eliassen.com for assistance. It is unlawful in Massachusetts and Maryland to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Applicants with disabilities that believe they require an accommodation or assistance with a position, please email our HR team at hradmin@eliassen.com. This email inbox is designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Emails sent for other purposes will not receive a response.
Please be advised that a number of fraudulent job postings have been released under the Eliassen Group brand.
Unfortunately, fraudulent job postings can happen. If anyone reaches out to you about an open position connected with Eliassen Group, never provide personal or financial information to anyone who is not clearly associated with Eliassen Group
If anyone seemingly from Eliassen Group has ever requested this personal information in the past or does so in the future, please contact fraud@eliassen.com.
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 will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group, as indicated above