Systems Engineer (Requirement Traceability

Job Title:
Systems Engineer (Medical Device)

• 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 Outputs
• 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.

• Bachelor's degree in Electrical (EE) or SW Engineering.
• 5 years with bachelor's degree and 3 with Masters.