System Engineer

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

• 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.

Requirements:

• Bachelor's degree in EE or SW Engineering.
• 5 years w/bachelor's degree and 3 with Masters.
• Requirements tracing experience

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.