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Sr Principal Engineer - Software Quality

United Kingdom, Gloucester · Job Posted June 29, 2026
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Job Description

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. The Sr. Principal Engineer, Quality applies a deep and broad understanding of software engineering principles, quality engineering practices, and regulatory requirements to lead the continuous improvement of software-enabled medical and non-medical products. This role spans regulated medical device software (e.g., IEC 62304) as well as non-medical digital solutions, ensuring scalable, compliant, and high-quality software delivery across diverse platforms. This role plans, executes, and functionally directs quality programs requiring independent judgment, technical authority, and cross‑functional leadership. The individual serves as a recognized technical expert in software quality, and Quality Management System (QMS) integration, ensuring alignment with ISO 13485 and EU MDR requirements while enabling modern software development practices.

Job Responsibility

  • Lead and govern activities that ensure alignment with Baxter's Product Lifecycle Management (PDLM) and Change Control Management (CCM) processes and compliance with design controls and quality system regulations
  • Translate Agile software development practices into compliant frameworks that meet Baxter, ISO 13485 and EU MDR expectations, including traceability, documentation, verification, and validation
  • Ensure effective implementation of software design controls, including: Software requirements and architecture
  • Risk management (software hazard analysis, cybersecurity risk)
  • Verification and validation strategies (manual, automated, CI/CD pipelines)
  • Configuration and change management
  • Lead integration of Quality Management System (QMS) processes into software development workflows, including: CAPA and nonconformance handling
  • Complaint handling and feedback loops into Agile backlogs
  • Audit readiness and inspection support
  • Ensure compliance with EU MDR requirements, including: Support for technical documentation and software lifecycle evidence
  • Alignment of software changes with regulatory impact assessments
  • Post-market surveillance inputs (e.g., trending, signal detection)
  • Apply advanced quality and engineering tools including root cause analysis, reliability engineering, and data analytics to improve software quality and system performance
  • Oversee development of technical documentation supporting: Design history files (DHF) / technical files
  • Software lifecycle documentation (per IEC 62304 where applicable)
  • Risk management files
  • Verification and validation reports
  • Regulatory submissions
  • Serve as subject matter expert for software quality, cybersecurity, and lifecycle management, providing guidance across teams and influencing enterprise-wide standards
  • Collaborate closely with Quality, Regulatory Affairs, R&D (software and systems), Product Management, Cybersecurity, Clinical, and Manufacturing teams to ensure software products are safe, effective, secure, and compliant

Requirements

  • Bachelor of Science or Bachelor of Engineering in Software Engineering, Computer Science, Electrical, Biomedical, or related discipline required
  • Master's degree or PhD preferred with 10+ years of progressive experience in software quality engineering, including regulated medical device software and/or digital health platforms
  • Strong expertise in: ISO 13485 Quality Management Systems
  • EU MDR (Regulation (EU) 2017/745) and software implications
  • Software lifecycle standards (e.g., IEC 62304, IEC 82304 where applicable)
  • FDA software and quality system expectations
  • Proven ability to integrate Agile development practices with regulatory compliance, including traceability, documentation, and change management
  • Broad understanding of: Software architecture and system integration
  • Cloud-based systems, cybersecurity, and data privacy considerations
  • Software risk management, including hazard analysis and vulnerability management
  • Strong technical leadership with advanced problem-solving, analytical, and decision-making skills

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

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