Senior Software Quality Engineer – CST – Lafayette, CO (Onsite)
Core
Lead software quality engineering and verification/validation for AI-enabled medical device software (AiBLE) throughout the SDLC.
Role type
Senior Software Quality Engineer (Regulated Industry)
Builds
AI-enabled surgical planning and navigation software for cranial and spinal procedures
Domain
Medical Devices / Artificial Intelligence / Software Quality Assurance
Deliverable
production ML models | product features
Required skills
Software Quality Engineering, Verification & Validation, SDLC processes, Design Control, Risk Management, Technical Documentation Review, Cross-functional Collaboration
Preferred skills
Medical Device Industry experience, FDA regulations, IEC 62304, ISO 13485, SaMD, Test Automation, Python, C++, MATLAB, ISO 14971
Technologies
Python, C++, MATLAB
Responsibilities
Lead software quality engineering activities across requirements, design, development, integration, testing, release, and validation; Ensure software products comply with quality system and regulatory requirements; Drive software verification and validation activities ensuring traceability and test coverage; Review software architecture, design documentation, and risk management documentation; Develop and maintain software quality processes and standards; Analyze quality metrics to support continuous improvement; Partner with cross-functional teams to resolve software quality issues.
Seniority
Senior, hands-on IC
