Zvh
Gloucester, Gloucestershire
Senior Principal Engineer, Quality 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. The 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. Responsibilities 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 such as 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, and 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. Qualifications 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 and EU MDR (Regulation (EU) 2017/745) and software implications. Proficiency in software lifecycle standards (e.g., IEC 62304, IEC 82304 where applicable) and 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. Strong understanding of software risk management, including hazard analysis and vulnerability management. Strong technical leadership with advanced problem-solving, analytical, and decision-making skills. Equal Employment Opportunity 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. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.
Senior Principal Engineer, Quality 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. The 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. Responsibilities 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 such as 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, and 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. Qualifications 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 and EU MDR (Regulation (EU) 2017/745) and software implications. Proficiency in software lifecycle standards (e.g., IEC 62304, IEC 82304 where applicable) and 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. Strong understanding of software risk management, including hazard analysis and vulnerability management. Strong technical leadership with advanced problem-solving, analytical, and decision-making skills. Equal Employment Opportunity 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. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.