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Baxter Logo Baxter · Research and Development

Sr Principal Engineer - Software Quality

United Kingdom, Gloucester · Job Posted June 30, 2026
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Job Description

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

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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