Senior Quality Engineer
Core
Lead verification, validation, and maintenance of host systems supporting Tempus Medical Devices and AI applications to ensure regulatory compliance and clinical safety.
Role type
Senior Quality Engineer (Medical Device Software)
Builds
FDA-regulated medical device software and AI clinical care platforms
Domain
Healthcare / Medical Devices / AI
Deliverable
production ML models
Required skills
Computer System Validation (CSV), Risk Assessment, FDA 21 CFR Part 11, ISO 13485, GAMP5, Design Controls, Change Management, User Acceptance Testing (UAT), Software Life Cycle Processes (IEC 62304)
Preferred skills
Biomedical or Software Engineering background, experience in life sciences industry
Technologies
AI applications, SaaS platforms, Medical Device Software
Responsibilities
Lead verification and validation of host systems; Conduct risk assessments for testing strategies; Develop and maintain CSV policies and procedures; Author validation deliverables (Protocols, Reports, Risk Assessments); Collaborate on test-driven requirements and execution; Support Change Management and Major Incidents; Provide mentorship to test engineers.
Seniority
Senior, hands-on IC with mentorship responsibilities