Sr Principal Software Design Quality Engineer - Relocation Assistance Provided Raleigh, NC

Job description

Problem Solver Analytical Thinker Data Driven Solution Focused & Results Oriented Collaborative Innovative Sr Principal Software Design Quality Engineer - Relocation Assistance Provided Apply Now 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. Your role at Baxter The Senior Principal Engineer, Software Design Quality serves as a senior technical authority for software design quality and design assurance throughout the product lifecycle. This position provides independent Quality leadership to ensure software and software-intensive medical devices are developed, verified, validated, released, and maintained in accordance with applicable design controls, software lifecycle processes, risk management requirements, regulatory requirements, and the Quality Management System. The primary focus is embedded software used in electromechanical medical devices, with potential future support for PC-based, web-based, connected, or interoperable software. Your Team The Senior Principal Engineer partners with Software Engineering, Systems Engineering, Product Security, Human Factors, Regulatory Affairs, Medical/Clinical, Manufacturing, Post-Market Quality, and other functions to establish appropriate quality strategies and ensure that software product risks are identified[GC1.1][SF1.2], understood, controlled, and supported by objective evidence. The role operates with a high degree of independence and is expected to influence technical and quality strategy across programs and product platforms. As the senior Software Design Quality representative, the individual is expected to make and defend difficult quality, safety, compliance, and release decisions with limited day-to-day supervision. The work will frequently involve iterative software releases, defect corrections, sustaining changes, and significant updates to existing requirements, traceability, and risk-management documentation in addition to traditional new-product development. The Senior Principal Engineer applies advanced engineering judgment to complex or ambiguous issues, challenges assumptions constructively, identifies systemic risks, and drives technically sound solutions that support safe, effective, reliable, and compliant medical devices. What you will be doing: Serve as the senior Design Quality technical authority for medical device software projects across the full product lifecycle. Provide Design Quality oversight primarily for embedded software used in electromechanical medical devices, with the ability to support PC-based, web-based, connected, and interoperable software as product needs evolve. Provide independent Quality leadership for software development, sustaining engineering, design changes, and release decisions. Operate independently and make risk-based quality decisions with limited day-to-day supervision from geographically dispersed teams. Establish risk-based software Design Quality strategies aligned with intended use, product architecture, development methodology, and regulatory expectations. Demonstrate understanding of and ensure adherence to applicable FDA regulations, ISO and IEC standards, design controls, software lifecycle processes, and Quality System requirements within the area of responsibility and expertise. Effect positive change on internal processes to improve team efficiency while maintaining the highest quality standards Provide Quality oversight of software lifecycle plans and deliverables from concept and planning through development, release, maintenance, and retirement. Lead Quality oversight of iterative software releases, sustaining changes, defect corrections, cybersecurity updates, and significant revisions to software requirements, traceability, and risk-management documentation. Evaluate software requirements for completeness, clarity, consistency, testability, allocation, and linkage to user needs and system requirements. Ensure end-to-end traceability among requirements, architecture, risk controls, implementation, verification, validation, anomalies, and release evidence. Lead Quality oversight of software risk management, including hazard analysis, risk-control implementation, traceability, and verification. Provide independent Quality oversight of software verification and validation strategies, methods, acceptance criteria, coverage, and results. Oversee the characterization, investigation, risk assessment, disposition, and closure of software anomalies and defects. Evaluate unresolved anomalies and failed, incomplete, or inconclusive testing for potential impact on safety, effectiveness, essential performance, compliance, and release readiness. Lead or support software release-readiness assessments and escalate unresolved technical, quality, safety, or compliance concerns when evidence is insufficient. Provide Quality oversight of software configuration management and design changes, including impact assessment, risk evaluation, testing scope, traceability, and approval. Provide Design Quality expertise for complex complaints, nonconformances, CAPAs, trend investigations, field issues, and root-cause investigations. Evaluate software defects, unresolved anomalies, complaints, post-market signals, and released-product risks to determine whether correction, removal, field action, or escalation to the Field Action Review Board or other formal governance process is warranted. Lead resolution of complex, ambiguous, or cross-functional software quality issues and ensure resulting corrective and preventive actions are technically justified, appropriately verified, and translated into systemic improvements using objective evidence, engineering judgment, and risk-based reasoning. Support internal and external audits, regulatory inspections, submissions, inquiries, and responses involving software design controls and lifecycle evidence. Communicate Quality positions and technical risks clearly to engineers, cross-functional partners, and senior leadership while maintaining independent judgment. Experience utilizing AI-assisted and advanced analytical tools, with appropriate human oversight, within Software Quality Mentor Design Quality engineers and promote scalable best practices, lessons learned, and continuous improvement across products and platforms. What you will bring: Completely proficient in 21 CFR 820.30 - Design Controls, ISO 13485, ISO 14971, IEC 62304, and Quality System and regulatory requirements applicable to medical-device software. Demonstrated ability to apply risk-based decision making throughout software development and maintenance activities. Completely proficient in software requirements engineering, including development, analysis, allocation, and traceability of software requirements. Completely proficient in software anomaly and defect management, including characterization, investigation, risk assessment, disposition, and closure. Completely proficient in software configuration management, including configuration identification, change control, status accounting, and release management. Completely proficient in product and process development concepts, including change control and risk management. Problem Solving - Apply structured root-cause analysis, engineering judgment, risk evaluation, objective evidence,