Sr Principal Software Design Quality Engineer - Relocation Assistance Provided

Responsibilities: Serve as the senior Design Quality technical authority for software projects across the product lifecycle Provide independent Quality leadership for software development, sustaining engineering, design changes, and release decisions Establish risk-based Design Quality strategies aligned with product architecture and regulatory expectations Ensure adherence to FDA regulations, ISO/IEC standards, design controls, software lifecycle processes, and QMS requirements Lead Quality oversight of software lifecycle plans, requires traceability from concept to retirement Oversee software risk management, including hazard analysis, risk-control implementation, and verification Provide independent oversight of verification and validation strategies, methods, criteria, and coverage Evaluate software defects, anomalies, and post-market signals for corrective actions or escalation Lead or support release-readiness assessments and escalate concerns when evidence is insufficient Provide Design Quality expertise for nonconformances, CAPAs, and root-cause investigations Support audits, regulatory inspections, submissions, and inquiries related to software design controls Mentor Design Quality engineers and promote scalable best practices

Key requirements: Completely proficient in 21 CFR 820.30 - Design Controls, ISO 13485, ISO 14971, IEC 62304, and applicable regulatory requirements for medical-device software Ability to apply risk-based decision making throughout software development and maintenance Proficiency in software requirements engineering, including traceability Proficiency in software anomaly and defect management, including risk assessment and closure Proficiency in software configuration management and release management Experience with change control and risk management within product and process development Proven leadership to make and defend difficult quality and release decisions with objective evidence Experience leading geographically distributed cross-functional teams Experience with embedded software in regulated devices; PC-based/web/connected software experience desired Experience assessing post-market issues for corrective actions or governance escalation Experience with AI-assisted and advanced analytical tools in Software Quality ASQ Certified Quality Engineer or equivalent preferred 8+ years in Quality Engineering with 5+ years in software Design Quality; experience in embedded medical-device software Educations: Bachelor's/Master’s in relevant engineering/science field Advanced training in software quality, cybersecurity is a plus Problem solving Leadership Independent work Software design quality Regulatory compliance (FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304) Software lifecycle and configuration management