Senior Medical Device Systems Engineer - Regulated Hardware

Theuniversityunion; Arden Hills (MN); On-site; USD 110,000 - 165,000; Full time

Job summary

ECI is seeking a Senior Systems Engineer to lead design, integration, verification, and lifecycle support of complex electrical systems for medical devices. The role blends electrical engineering, systems engineering, risk management, and cross-functional collaboration to deliver safe, regulatory-compliant products.

The ideal candidate has deep experience in medical device development, including hardware architecture, embedded systems integration, verification and validation, and

Qualifications

• 7–12+ years of experience in electrical or systems engineering.
• Experience developing regulated medical devices.
• Bachelor’s or Master’s degree in Electrical Engineering or related field.

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, 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

Requirements tracing

Traceability

System engineering

Regulatory compliance

Risk management

Cross-functional collaboration

Electrical design

Embedded systems

Test & troubleshooting

Education

Bachelor’s or Master’s degree in Electrical Engineering or related field

Tools

Cockpit

Oscilloscope

Logic analyzer

Spectrum analyzer

Power analyzer

Job description

ECI is seeking a Senior Systems Engineer to lead design, integration, verification, and lifecycle support of complex electrical systems for medical devices. The role blends electrical engineering, systems engineering, risk management, and cross-functional collaboration to deliver safe, regulatory-compliant products.

The ideal candidate has deep experience in medical device development, including hardware architecture, embedded systems integration, verification and validation, and