Systems Requirements Engineer - Traceability & Compliance

Entegee; Arden Hills (MN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K plan

Paid leave

Commuter benefits

Job summary

Entegee in Arden Hills, MN seeks a Requirements Engineer to support Design History Files (DHF) and regulatory submissions by ensuring traceability and compliance through product development.

You will review requirements, maintain traceability matrices, and collaborate with cross-functional teams to assess design-change impacts and verify evidence of compliance. Equal Opportunity Employer/Veterans/Disabled.

Qualifications

• Bachelor's degree in EE or SW Engineering.
• 5 years with Bachelor's degree and 3 years with a Master's.
• Proven requirements tracing experience.

Responsibilities

• Review requirements to ensure clarity, completeness, testability, and compliance with internal standards.
• Develop and maintain traceability matrices and DHF artifacts.
• Partner with cross-functional teams to assess traceability impacts of design changes and ensure updates are implemented.
• Facilitate requirements reviews and traceability assessments throughout product development and integration.
• Support gap assessments to identify missing or improperly linked requirements and verification evidence.
• Verify requirements are linked to verification/validation activities with objective evidence of compliance.
• Support regulatory submissions, audits, and inspections with traceability documentation and rationale.
• Collaborate with Risk Management to trace hazards and risk controls to design requirements and testing.

Skills

Requirements tracing

Traceability management

Cross-functional collaboration

Education

Bachelor's degree in EE or SW Engineering

Master's degree (optional) in EE or SW Engineering

Job description

Entegee in Arden Hills, MN seeks a Requirements Engineer to support Design History Files (DHF) and regulatory submissions by ensuring traceability and compliance through product development.

You will review requirements, maintain traceability matrices, and collaborate with cross-functional teams to assess design-change impacts and verify evidence of compliance. Equal Opportunity Employer/Veterans/Disabled.