Senior Software Quality Engineer - Design Assurance & AI Tools

Baxter International Inc.; Round Lake (IL); On-site; USD 105,000 - 135,000; Full time

Job summary

A major medical device company in Round Lake, Illinois, seeks a Principal Quality Engineer to ensure the safety and compliance of medical device software. This role involves reviewing software architectures, assessing verification strategies, and identifying key quality metrics. Candidates should have extensive software development experience and regulatory compliance expertise, ideally in medical devices. An advanced degree is preferred.

Qualifications

• 10+ years of experience in software development, testing, or architecture for regulated industries.
• Strong understanding of IEC 62304 software lifecycle requirements.
• Ability to critically evaluate verification strategies, test coverage, and architecture robustness.

Responsibilities

• Review and challenge software architectures for technical adequacy.
• Assess the sufficiency of software verification strategies.
• Define and report key software quality metrics.

Skills

Software development experience (10+ years)

Knowledge of IEC 62304 software lifecycle

Experience with static/dynamic code analysis tools

Familiarity with CI/CD pipelines

Problem-solving skills

Education

Bachelor's degree in Computer Science or Software Engineering

Advanced degree (MS or higher) in Computer Science or Engineering

Tools

Polyspace

Coverity

GitHub Actions

Jenkins

Azure DevOps

Job description

A major medical device company in Round Lake, Illinois, seeks a Principal Quality Engineer to ensure the safety and compliance of medical device software. This role involves reviewing software architectures, assessing verification strategies, and identifying key quality metrics. Candidates should have extensive software development experience and regulatory compliance expertise, ideally in medical devices. An advanced degree is preferred.