Principal Quality Engineer - (Software Design Assurance) at Baxter International

Round Lake, Illinois, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

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
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

Responsibilities

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)
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
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
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
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

Skills

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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