Systems Engineer (Requirement Traceability)

REQ Solutions; Saint Paul (MN); Hybrid; USD 90,000 - 130,000; Full time

Job summary

REQ Solutions in Minnesota is seeking a Systems Engineer (Medical Device) for a hybrid role. You will create and maintain requirements tracing in Cognition Cockpit and translate offline efforts into traceability artifacts across user needs, intended use, product claims, and design inputs/outputs.

You will collaborate with Risk Management and cross-functional teams to ensure proper linkage to verification, validation, and regulatory submissions, while maintaining DHF evidence and traceability

Qualifications

• Ability to create and maintain requirements tracing/documents.
• Experience in ensuring traceability from user needs to verification and validation.
• Familiarity with Design History Files (DHF) and regulatory submissions.

Responsibilities

• Create and maintain requirements tracing in Cognition Cockpit.
• Translate offline requirements to Cognition Cockpit with team.
• Establish end-to-end traceability across system and hardware/software elements.
• Maintain DHF artifacts and support regulatory readiness.

Skills

Requirements tracing

Cross-functional collaboration

Traceability mindset

Education

Electrical Engineering

Software Engineering

Master's degree (EE/CS)

Tools

Cognition Cockpit

Job description

Job Title: Systems Engineer (Medical Device)

Hybrid Role

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 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.

Education/Experience

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