Principal Quality Engineer - (Software Design Assurance)

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your role at Baxter:

The Principal Quality Engineer plays a critical role in ensuring the safety, effectiveness, and regulatory compliance of our medical device software. This role brings deep technical expertise in software development, architecture, CI/CD practices, and modern AI/software-quality tools to strengthen design assurance. The Principal Quality Engineer partners with R&D teams to independently evaluate the adequacy of software requirements, architectures, risk controls, and verification strategies, ensuring alignment with IEC 62304, ISO 14971, and FDA/EU MDR expectations. The Principal Quality Engineer also defines and tracks software quality metrics to measure assurance effectiveness and proactively identify systemic risks.

What you will be doing:

Design Assurance & Oversight

• Review and challenge software architectures, designs, and requirements for technical adequacy, safety, and robustness.
• Assess the sufficiency of software verification & validation strategies (without executing tests).
• Ensure risk mitigations (per ISO 14971) are properly implemented and verified at the appropriate software safety class (A/B/C).

Technical Reviews

• Lead and participate in architecture reviews, static/dynamic analysis reviews, and anomaly investigations from a Quality perspective.
• Evaluate SOUP (software of unknown provenance) risk assessments and mitigation strategies.
• Provide technical input into CAPA investigations related to software anomalies and field performance.

Software Quality Metrics

• Define, monitor, and report key software quality metrics (e.g., defect removal efficiency, defect leakage, phase containment effectiveness, test adequacy).
• Use metrics to proactively identify risks, drive improvements, and inform leadership.
• Partner with development and test teams to ensure metrics are visible at program and portfolio levels.

Operationalizing AI/Modern Quality Tools

• Evaluate and implement AI-enabled software quality tools (e.g., AI-assisted test automation, AI-generated unit tests, visual regression AI).
• Operationalize these tools within a regulated environment, including: defining intended use and scope, performing tool validation (CSV), risk assessments, governance frameworks, and audit-ready documentation.
• Ensure safe adoption by defining human-in-the-loop review and risk-based controls for AI-generated artifacts.

Cross-Functional Collaboration

• Partner with Systems, Software Development, and Test teams to ensure compliance and technical rigor.
• Serve as the Quality function’s technical voice in design reviews and governance boards.
• Mentor and coach process-focused SQEs to raise overall technical fluency in the team.

What do you bring:

Required:

• Bachelor’s degree in Computer Science or Software Engineering
• 10+ years of experience in software development, testing, or architecture for regulated industries (medical devices preferred).
• Strong understanding of IEC 62304 software lifecycle requirements and ISO 14971 risk management.
• Display basic understanding of Design Controls and Change Control principles.
• Experience with static/dynamic code analysis tools (e.g., Polyspace, Coverity).
• Hands-on experience with one or more: embedded systems, real-time software, fault-tolerant design, or cybersecurity.
• Ability to critically evaluate verification strategies, test coverage, and architecture robustness.

Preferred:

• Prior experience in a software quality, design assurance, or regulatory compliance role.
• Experience with CI/CD pipelines (e.g., GitHub Actions, GitLab CI, Jenkins, Azure DevOps).
• Familiarity with AI / modern software-quality tools such as: AI-assisted test creation, visual AI validation for regression detection, AI-generated unit test frameworks.
• Experience operationalizing AI tools in medical devices —