Lead Systems Verification Engineer - Medical Devices

Baxter International Inc.; Round Lake (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) Retirement Savings Plan with

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Bonus potential

Job summary

Baxter International Inc. in Round Lake, IL is seeking a Principal Systems Verification Engineer to lead system verification activities within the Infusion Therapies & Platforms division. You will guide test planning, validation, and documentation to ensure compliance with FDA/ISO standards.

The role requires 5+ years of relevant experience, strong communication, and the ability to mentor engineers across sites. A competitive salary and comprehensive benefits are provided.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 5+ years of industry experience.
• Medical device industry experience preferred.
• Strong organization and communication skills with both technical and non-technical personnel.
• Knowledge of ISO, FDA and other regulatory standards.

Responsibilities

• Lead planning, development and execution of system verification deliverables and provide technical direction.
• Lead validation efforts for laboratory equipment used in infusion system testing.
• Develop and execute validation protocols, test plans, and reports per FDA/ISO standards.
• Perform IQ/OQ/PQ activities with traceability from requirements to tests.
• Contribute to system requirements, architecture and design documentation.
• Create best practices and traceability to streamline testing across system, subsystem, and software verification.
• Implement configuration and change management throughout the product life cycle.
• Mentor junior engineers and communicate team capabilities to stakeholders.
• Advance test automation and optimize test processes.

Skills

System verification

Test automation

Leadership

Regulatory knowledge

Communication skills

Education

Bachelor's degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or related field

Tools

Automation framework

Job description

Baxter International Inc. in Round Lake, IL is seeking a Principal Systems Verification Engineer to lead system verification activities within the Infusion Therapies & Platforms division. You will guide test planning, validation, and documentation to ensure compliance with FDA/ISO standards.

The role requires 5+ years of relevant experience, strong communication, and the ability to mentor engineers across sites. A competitive salary and comprehensive benefits are provided.