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.

• 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.

• 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.

• Prior experience in a software quality, design assurance, or regulatory compliance role.
• Experience with CI/CD pipelines (e.g., Git Hub Actions, Git Lab CI, Jenkins, Azure Dev Ops).
• 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 — including validation (CSV), risk assessments, governance frameworks, and preparing audit‑ready documentation.
• Familiarity with human factors (IEC 62366) and cybersecurity frameworks (e.g., FDA guidance, UL 2900).
• Advanced degree (MS or higher) in Computer Science, Engineering, or related field.

• Strong critical thinking and problem‑solving skills.
• Ability to “speak the…