Senior Systems Engineer - Medical Device -Cardiac #2323

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

• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree

Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About the role

We are seeking a Senior Systems Engineer to lead the design, integration, verification, and lifecycle support of complex electrical systems for medical devices. This role combines electrical engineering, systems engineering, risk management, and cross-functional collaboration to develop safe, reliable, and regulatory-compliant products. The ideal candidate has strong experience in medical device development, including hardware architecture, embedded systems integration, verification and validation, and compliance with FDA and international standards.

What you will do

• 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.

What you will bring

• 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

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.