Senior Systems Engineer — Medical Devices & Regulatory Traceability

ECI; Minneapolis (MN); On-site; USD 120,000 - 180,000; 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. You will apply electrical and systems engineering, risk management, and regulatory compliance to deliver safe, reliable products.

The role requires strong experience in medical device development, 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 with medical device development and regulatory standards.
• Strong understanding of analog and digital circuit design; embedded systems; power management; EMI/EMC; system integration.

Responsibilities

• Create and maintain design requirements and traceability across the product lifecycle.
• Lead design, integration, verification, and lifecycle support of electrical systems for medical devices.
• Collaborate with cross-functional teams to assess design changes and maintain traceability.
• Support regulatory submissions, audits, and inspections with traceability documentation.

Skills

Embedded systems

Power management

Signal integrity

EMC

System integration

Troubleshooting

Regulatory compliance

Education

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

Tools

Oscilloscopes

Logic analyzers

Spectrum analyzers

Power analyzers

Job description

ECI is seeking a Senior Systems Engineer to lead design, integration, verification, and lifecycle support of complex electrical systems for medical devices. You will apply electrical and systems engineering, risk management, and regulatory compliance to deliver safe, reliable products.

The role requires strong experience in medical device development, hardware architecture, embedded systems, verification/validation, and FDA/international standards.