Senior Quality Assurance Design Transfer Engineer I
Core
Senior Quality Assurance Design Transfer Engineer ensuring design requirements are appropriately transferred into manufacturing for medical devices, managing design controls, risk management, and validation activities.
Role type
Senior IC Quality Assurance Design Transfer Engineer
Builds
Medical devices and manufacturing processes
Domain
Medical Devices / Quality Engineering / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control management, Risk Analysis/Management, Engineering Change Notification (ECN) handling, Test Method Validation (TMV), Master Validation Plans (MVP), IQ/OQ/PQ Validation, Root Cause Investigation, Lean Manufacturing, Six Sigma, Project Management, Quality System Compliance (21 CFR 820, ISO 13485)
Preferred skills
Minitab, JMP, Oracle, ASQ Certified Quality Engineering
Technologies
Minitab, JMP, Oracle, Spreadsheets, Word Processing, Database software
Responsibilities
Guide design teams as subject matter expert for Design Control from Inputs through Outputs and Process Validation; Coordinate and lead risk management analysis meetings and mitigation; Review, approve, and generate Engineering Change Notifications (ECNs); Conduct conceptually related studies for novel technical problems; Mentor engineers and technicians on engineering projects and quality compliance; Review nonconformance records to determine disposition and corrective actions; Ensure containment of nonconforming product; Evaluate and maintain the effectiveness of the quality management system; Support Internal and supplier audit activities.
Seniority
Senior, hands-on IC with mentorship responsibilities
