Principal Quality Engineer - (Software Design Assurance)

This is whereyour 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 Principal Quality Engineer plays a critical role in ensuring the safety, effectiveness, and regulatory compliance of our medical device software. This role brings deep technical expertise in software development, architecture, CI/CD practices, and modern AI/software-quality tools to strengthen design assurance. The Principal Quality Engineer partners with R&D teams to independently evaluate the adequacy of software requirements, architectures, risk controls, and verification strategies, ensuring alignment with IEC 62304, ISO 14971, and FDA/EU MDR expectations. The Principal Quality Engineer also defines and tracks software quality metrics to measure assurance effectiveness and proactively identify systemic risks.

What you will be doing:

Design Assurance & Oversight

• Review and challenge software architectures, designs, and requirements for technical adequacy, safety, and robustness.
• Assess the sufficiency of software verification & validation strategies (without executing tests).
• Ensure risk mitigations (per ISO 14971) are properly implemented and verified at the appropriate software safety class (A/B/C).

Technical Reviews

• Lead and participate in architecture reviews, static/dynamic analysis reviews, and anomaly investigations from a Quality perspective.
• Evaluate SOUP (software of unknown provenance) risk assessments and mitigation strategies.
• Provide technical input into CAPA investigations related to software anomalies and field performance.

Software Quality Metrics

• Define, monitor, and report key software quality metrics (e.g., defect removal efficiency, defect leakage, phase containment effectiveness, test adequacy).
• Use metrics to proactively identify risks, drive improvements, and inform leadership.
• Partner with development and test teams to ensure metrics are visible at program and portfolio levels.

Operationalizing AI/Modern Quality Tools

• Evaluate and implement AI-enabled software quality tools (e.g., AI-assisted test automation, AI-generated unit tests, visual regression AI).
• Operationalize these tools within a regulated environment, including: defining intended use and scope, performing tool validation (CSV), risk assessments, governance frameworks, and audit-ready documentation.
• Ensure safe adoption by defining human-in-the-loop review and risk-based controls for AI-generated artifacts.

Cross-Functional Collaboration

• Partner with Systems, Software Development, and Test teams to ensure compliance and technical rigor.
• Serve as the Quality function's technical voice in design reviews and governance boards.
• Mentor and coach process-focused SQEs to raise overall technical fluency in the team.

What do you bring:

Required:

• Bachelor's degree in Computer Science or Software Engineering
• 10+ years of experience in software development, testing, or architecture for regulated industries (medical devices preferred).
• Strong understanding of IEC 62304 software lifecycle requirements and ISO 14971 risk management.
• Display basic understanding of Design Controls and Change Control principles.
• Experience with static/dynamic code analysis tools (e.g., Polyspace, Coverity).
• Hands-on experience with one or more: embedded systems, real-time software, fault-tolerant design, or cybersecurity.
• Ability to critically evaluate verification strategies, test coverage, and architecture robustness.

Preferred:

• Prior experience in a software quality, design assurance, or regulatory compliance role.
• Experience with CI/CD pipelines (e.g., GitHub Actions, GitLab CI, Jenkins, Azure DevOps).
• Familiarity with AI / modern software-quality tools such as: AI-assisted test creation, visual AI validation for regression detection, AI-generated unit test frameworks.
• Experience operationalizing AI tools in medical devices - including validation (CSV), risk assessments, governance frameworks, and preparing audit-ready documentation.
• Familiarity with human factors (IEC 62366) and cybersecurity frameworks (e.g., FDA guidance, UL 2900).
• Advanced degree (MS or higher) in Computer Science, Engineering, or related field.

Key Attributes

• Strong critical thinking and problem-solving skills.
• Ability to "speak the language" of software developers while maintaining an independent Quality perspective.
• Comfortable challenging technical decisions in a constructive, collaborative way

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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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.

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