Sr Principal Engineer Software Quality

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 crossfunctional 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 youll be doing:

• Lead and govern activities that ensure alignment with Baxters 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 frameworksthat 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 analyticsto 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 teamsto ensure software products are safe effective secure and compliant

What youll bring:

Bachelor of Science or Bachelor of Engineering in Software Engineering Computer Science Electrical Biomedical or related discipline required. Masters 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.

Required Experience:

Staff IC

Employment Type : Full-Time
Experience: years
Vacancy: 1