Sr Principal Software Design Quality Engineer - Relocation Assistance Provided
Core
Senior technical authority for software design quality and assurance throughout the product lifecycle for embedded software in electromechanical medical devices.
Role type
Senior Principal Software Design Quality Engineer
Builds
Safe, effective, reliable, and compliant medical devices
Domain
Medical device software / Regulatory compliance
Required skills
21 CFR 820.30 Design Controls, ISO 13485, ISO 14971, IEC 62304, software requirements engineering, anomaly and defect management, configuration management, risk-based decision making, root-cause analysis, regulatory inspection support
Preferred skills
AI-assisted analytical tools, mentoring, cross-functional leadership
Technologies
Embedded software, PC-based software, web-based software, connected software, interoperable software
Responsibilities
Establish risk-based software Design Quality strategies aligned with regulatory expectations; Ensure adherence to FDA regulations, ISO/IEC standards, and Quality System requirements; Lead Quality oversight of iterative software releases, sustaining changes, and defect corrections; Evaluate software requirements for completeness, clarity, consistency, and testability; Ensure end-to-end traceability among requirements, architecture, risk controls, and release evidence; Lead Quality oversight of software verification and validation strategies; Oversee characterization and closure of software anomalies and defects; Lead resolution of complex, ambiguous, or cross-functional software quality issues; Support internal and external audits and regulatory inspections.
Seniority
Principal, independent technical authority