Duration: 12 months Contract Hybrid- 3 days onsite in AH.
Under W2 Hourly Contract
Key Responsibilities- Create and maintain requirements tracing in Cognition Cockpit
- Assist team in translating offline efforts for requirements/RCM/DOSR to Cognition Cockpit
- Establish and maintain end-to-end traceability across: User Needs, Intended Use and Product Claims, System and Subsystem Requirements, Design Inputs and Output, Risk Controls, Verification Activities, Validation Activities, Regulatory Requirements
- Review requirements documentation to ensure clarity, completeness, testability, and compliance with internal standards.
- Develop and maintain traceability matrices and requirements management artifacts supporting Design History Files (DHF).
- Partner with cross-functional teams to ensure design changes are assessed for traceability impacts and appropriate updates are implemented.
- Facilitate requirements reviews and traceability assessments throughout product development and integration activities.
- Support gap assessments to identify missing, incomplete, or improperly linked requirements and verification evidence.
- Verify that requirements are appropriately linked to verification and validation activities and that objective evidence exists demonstrating compliance.
- Support regulatory submissions, audits, and inspections by providing traceability documentation and rationale.
- Collaborate with Risk Management teams to ensure hazards, hazardous situations, and risk control measures are properly traced to design requirements and testing.
Qualifications- Bachelor's degree in EE or SW Engineering.
- 5 years w/bachelor's degree and 3 with Masters.
- Medical device experience
- Requirements tracing experience
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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