Sr Principal Engineer - Software Quality

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. Your Role at Baxter 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. What you'll be doing: 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 What you'll bring: 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 #LI#LR1 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 click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .