[Job Title]
Eastridge Workforce solutions is seeking a Sr Software Requirements & Systems Engineer for one of our top partners in the medical device manufacturing.
This is a TEMP opportunity, Pay $85-$90 / hr
This position focuses on requirements engineering, traceability, and compliance in a regulated environment - not hands-on coding. You'll collaborate closely with Systems Engineering, Software, Verification & Validation (V&V), Product, and Quality teams to ensure regulatory compliance and end-to-end requirements quality.
Key Responsibilities
- Elicit, write, and refine clear, testable software requirements from user needs and product specifications.
- Facilitate technical and cross-functional reviews; drive alignment and decision-making across teams.
- Build and maintain bidirectional traceability between user needs, hazards / risks, software requirements, design / architecture, and verification activities (in compliance with IEC 62304 and ISO 14971).
- Generate traceability reports for regulatory submissions and audits.
- Administer and improve requirements in ALM / PLM systems (e.g., Polarion, Helix ALM, or DOORS), including versioning and baselining.
- Review downstream artifacts (architecture / design documents, DFMEA / FMEA, test strategies, etc.) to ensure full requirements coverage.
- Partner with Product Owners to translate software requirements into Agile user stories with complete acceptance criteria.
- Contribute to continuous improvement of requirements engineering practices, templates, and workflows.
Qualifications
Required :
5+ years' experience supporting complex, safety-critical, or regulated products (medical device experience preferred; aerospace, automotive, or industrial safety acceptable).Demonstrated expertise in writing and managing software / system requirements - emphasizing clarity, decomposition, and testability.Strong knowledge of systems engineering concepts including requirements management, risk analysis, and software / system architecture.Proven experience working under a Quality Management System (QMS) and within design control environments.Proficiency with ALM tools such as Polarion, Helix ALM, or DOORS and an understanding of traceability best practices.Familiarity with Agile / Scrum development and aligning Definition of Ready / Done with regulatory expectations.Excellent communication, facilitation, and documentation skills.Preferred :
Knowledge of medical device standards : IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820.30.Certifications in Systems or Requirements Engineering (INCOSE, IREB / CPRE).Familiarity with diabetes management, IoT, mobile / cloud platforms, and cybersecurity / privacy (e.g., GDPR).Experience with PLM systems and change control.
Benefits : Use this link bit.ly / 4cGUQSh to learn more about benefits available to Eastridge's temporary employees. From time to time Eastridge's clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.
Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.
Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.