Systems Engineer (Requirement Traceability)

Job Title: Systems Engineer (Medical Device)Duration: 12+ Months (Possible extension)Location: Arden Hills, MN 55112Hybrid RoleResponsibilities:Create and maintain requirements tracing in Cognition CockpitAssist team in translating offline efforts for requirements/RCM/DOSR to Cognition CockpitEstablish and maintain end-to-end traceability across:User NeedsIntended Use and Product ClaimsSystem and Subsystem RequirementsDesign Inputs and OutputsRisk ControlsVerification ActivitiesValidation ActivitiesRegulatory RequirementsReview 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.Education/Experience:Bachelor's degree in Electrical (EE) or SW Engineering.5 years with bachelor's degree and 3 with Masters.Medical device experienceRequirements tracing experience