QA Design Transfer Engineer I/II - Pearland, TX
Core
Ensures design outputs are appropriately transferred into manufacturing for medical devices by guiding process validation, test method validation, and device master record creation.
Role type
Quality Assurance Design Transfer Engineer
Builds
Medical devices (implies production features)
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Validation, Test Method Validation, Device Master Record creation, Risk Management, Engineering Change Notifications (ECNs), Root Cause Analysis, Corrective and Preventive Actions (CAPA), Quality Management System maintenance, Statistical methodologies, Lean manufacturing, Six Sigma
Preferred skills
Minitab, Oracle, ASQ Certified Quality Engineering
Technologies
Minitab, Oracle
Responsibilities
Guide design team through Process Validation and Test Method Validation; Coordinate process risk analysis and management; Review and approve Engineering Change Notifications (ECNs); Conduct technical studies for novel problems; Review nonconformance records to determine disposition and root cause; Ensure containment of nonconforming product; Evaluate manufacturing work environment controls.
Seniority
Mid-level IC (I/II levels imply entry to mid-level)