Principal Engineer - Software 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. 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
  
  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
  
  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., 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., "For me, the best thing about working at Baxter is being able to do work that's important to people-especially patients-outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States "I'm excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care - whether in a hospital, a healthcare clinic, or the patient's home - anywhere in the world."

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.
• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
Success Profile What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we're looking for and see if you're a fit.
• Courage
• Action Oriented
• Collaborates
• Cultivates Innovation
• Manages Ambiguity
• Drives Results, Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.