Principal Quality Engineer Software Design Assurance

Principal Quality Engineer - Software Design Assurance

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.

• 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 across software safety classes (A/B/C).
• 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.
• 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.
• 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.
• 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.
• Preferred:
  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 6636) 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 language” of software developers while maintaining an independent Quality perspective.
• Comfortable challenging technical decisions in a constructive, collaborative way.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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