Sr Principal Software Design Quality Engineer

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.
• Ensure adherence to applicable FDA regulations, ISO and IEC standards, design controls, software lifecycle processes, and Quality System requirements.
• 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 is warranted.
• Lead resolution of complex, ambiguous, or cross-functional software quality issues and ensure corrective and preventive actions are technically justified and verified.
• 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.
• 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.
• Apply structured root-cause analysis, engineering judgment, risk evaluation, objective evidence, and appropriate statistical techniques to address complex issues and investigations.
• Proven leadership skills and demonstrated ability to independently make and defend difficult software quality, safety, compliance, and release decisions.
• Extensive experience leading and influencing geographically distributed cross-functional teams without direct authority.
• Extensive experience providing Design Quality oversight for embedded software in regulated electromechanical medical devices.
• Demonstrated experience assessing software defects and post-market issues for potential product correction, removal, field action, or escalation.
• Experience utilizing AI-assisted and advanced analytical tools within Software Quality.
• Bachelors or Master's Degree in Software Engineering, Computer Science, Computer Engineering, Electrical Engineering, or a related engineering/scientific discipline.
• Overall, 8+ years of Quality Engineering experience, including substantial direct experience in regulated software Design Quality and a minimum of 5+ years supporting software-centric projects.