Hybrid Systems Engineer - Medical Device 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

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