Senior Systems Engineer - Medical Devices & Regulatory Traceability

ECI; Arden Hills (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

ECI is seeking a Senior Systems Engineer in Minnesota to lead the design, integration, verification, and lifecycle support of complex electrical systems for medical devices.

The role combines electrical and systems engineering, risk management, and cross-functional collaboration to develop safe, regulatory-compliant products. Ideal candidates have experience with hardware architecture, embedded systems, verification/validation, and FDA/international standards.

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering or related field.
• 7–12+ years of experience in electrical or systems engineering.
• Experience developing regulated medical devices.
• Strong understanding of analog and digital circuit design; embedded systems; power management; signal integrity and EMC; system integration and troubleshooting.
• Experience with lab equipment like oscilloscopes; logic analyzers, spectrum analyzers and power analyzers.

Responsibilities

• Create and maintain requirements tracing in Cockpit
• Assist team in translating offline efforts for requirements/RCM/DOSR to Cockpit
• Establish and maintain end-to-end traceability across User Needs, Intended Use and Product Claims, System and Subsystem Requirements, Design Inputs and Outputs, Risk Controls, 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

Skills

Electrical engineering

Systems engineering

Regulated medical devices

Embedded systems

Risk management

Requirements tracing

Traceability

Verification & validation

Regulatory standards

EMC

Education

Bachelor’s or Master’s degree in Electrical Engineering

Tools

Cockpit

Job description

ECI is seeking a Senior Systems Engineer in Minnesota to lead the design, integration, verification, and lifecycle support of complex electrical systems for medical devices.

The role combines electrical and systems engineering, risk management, and cross-functional collaboration to develop safe, regulatory-compliant products. Ideal candidates have experience with hardware architecture, embedded systems, verification/validation, and FDA/international standards.