Baxter International Inc.
Sr Principal Engineer - Software Quality
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At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life.
Our Mission is to Save and Sustain Lives, and we are redefining healthcare delivery for greater impact. Here, colleagues are united by a culture of courage, trust, and collaboration, where every individual is empowered to take ownership and make a meaningful difference.
Here at Baxter, you will find more than just a job—you’ll find purpose and pride.
Senior Principal Engineer, Quality
The Sr. Principal Engineer, Quality applies deep and broad expertise in software engineering principles, quality engineering, regulatory requirements, and best practices to lead the continuous improvement of software-enabled medical and non-medical products. This multi-faceted role spans regulated medical device software (e.g., IEC 62304) alongside non-medical digital solutions, ensuring compliant, scalable, and high-quality software delivery across diverse platforms.
This leadership position plans, executes, and directs quality initiatives requiring independent judgment, cross-functional authority, and technical governance, serving as a recognized subject matter expert in software quality and Quality Management System (QMS) strategy. Your work will ensure alignment with ISO 13485 and EU MDR standards while promoting modern software development practices.
Key Responsibilities
Quality Governance & Compliance
- Lead and oversee Product Lifecycle Management (PDLM) and Change Control Management (CCM) compliance with design controls and quality system regulations.
- Translate Agile development practices into compliant frameworks, ensuring:
- Traceability and documentation for Baxter and applicable standards.
- Verification and validation aligned with regulatory and process requirements.
- Integration of CI/CD pipelines for automated testing and technology validation.
Software Engineering Quality Assurance
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Ensure robust software design controls, including:
- Architectural and design requirements alignment.
- Risk management (e.g., software hazard analysis, cybersecurity, and vulnerability controls).
- Verification and validation strategies for:
- Manual testing and data methodologies.
- Automated and AI-driven assurance processes.
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Guarantee configuration and change management to reduce technical debt and maintain high-quality processes.
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Quality Management System (QMS) Integration
- Unify QMS processes with software product development, including:
- CAPA/Nonconformance investigation and resolution.
- Complaint treatment and feedback system, feeding into Agile backlogs.
- Audit readiness and regulatory inspection preparation.
Regulatory & EU MDR Compliance
- Support technical documentation for post-market compliance, covering:
- Software lifecycle evidence packages (e.g., design history files, DHFs, technical files).
- Regulatory impact assessments for software changes.
- Post-market surveillance actions, such as signal detection and control plan updates.
Advanced Quality & Engineering
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Utilize root cause analysis, reliability assessments, and analytics-inspired automation to improve software performance.
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Oversee technical documentation for submission processes, including:
- Software Lifecycle Management reports (IEC 62304 compliant).
- Risk management files.
- Validation and traceability reports.
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Security and confidentiality: Implement requirements supporting cybersecurity controls in software design.
Strategic Leadership & Collaboration
- Act as SME for software quality, lifecycle management, and security standards, influencing global technical guidelines.
- Partner with cross-functional teams, including Quality, Regulatory Affairs, R&D (software & systems), Product Management, Cybersecurity, Clinical Operations, and Manufacturing, to ensure products adhering to Baxter’s rigorous standards for safety, security, and compliance.
What We’re Looking For
A Bachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or related discipline is essential. Preferred options include:
- Masters or Ph.D. with 10+ years of progressive expertise in regulated medical device software and/or digital health platforms.
- Advanced technical licensing or professional certifications (e.g., CQE, CMQ/OE, ISO/IPM program accommodations) would be advantageous.
Key Technical Qualifications and Experience:
- Comprehensive expertise in ISO 13485 Quality Management Systems and EU MDR (Regulation (EU) 2017/745).
- Strong experience with Agile methodologies, eliminating softانا and ensures processes meet regulator expectations for traceability, change tracking, and test validation.
- Deep understanding of software architecture, system integration, risk control plans, and configuration compliance.
- Experience with cloud-based deployments, cybersecurity compliance frameworks, and privacy regulations (e.g., GDPR).
- Core knowledge in medical software design standards: IEC 62304, SSharf, and FDA guidance.
- Proficient in data analysis tools such as Python, SQL, or cloud analytics to drive quality decisions.
- Cultural fit with Baxter’s commitment to accountability, collaboration, and scalable innovation.
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Why Baxter?
Here at Baxter, we provide more than employment—we offer purpose, respect, and prestige. Supporting a company with a clear Legacy of Impact since 1931? Reimagine healthcare every day with individuals passionate enough to shape the industry.
Baxter has always believed our voice is amplified when its unique. Here’s what we’re known for:
🔹 Inclusion & Diversity – Thriving in an environment that celebrates everyone. 🔹 Competitive Compensation – Recognition with market-leading benefits. 🔹 Global Impact – Turning ideas into life-saving solutions that change lives.
Join a team of empowered, passionate professionals on a mission—here at Baxter, the boundaries of what’s possible and what’s right go beyond limits. Your workmaking a difference.
Equal Opportunity Employment
Baxter is an equal opportunity employer. We evaluate all qualified applicants without regard to race, color, religion, gender, age, national origin, sexual orientation, gender identity or expression, protected veteran status, disability, parenthood, genetic information, or any other legally protected characteristic.
Accommodations Notice
If you require an accommodation for any part of the application or interview process due to a disability or medical condition, please contact supporting staff here to discuss your request.
Recruitment Fraud Awareness
Baxter has noticed scam incidents where fraudsters impersonate Baxter staff, recruiters, or officials. Protect yourself by educating yourself on common scams, how to verify sources, and recognizing less legal requests; review the lastest updates here.
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