Advanced Design Quality Engineer
Core
Ensures design control process compliance and validates design inputs (usability, reliability, safety) for new product transitions to production.
Role type
Senior IC design quality engineer
Builds
Hardware, software, and system designs compliant with regulatory standards
Domain
Medical device manufacturing and quality engineering
Required skills
Design Quality Management, Root Cause Analysis, Regulatory Compliance, Statistical Process Validation, Risk Management, Technical Documentation, Continuous Improvement, Defect Management, Design Verification Planning, Design Validation Planning
Preferred skills
Six Sigma Green Belt, Data Analysis, Design for Quality (DFQ), CAPA Methodologies, Post Market Surveillance (PMS), Privacy and Security Risk Assessment, Product Test Design
Responsibilities
Guide implementation of process validation plans using statistical tools; Ensure smooth execution of design control from inputs to transfer; Review and assess quality engineering documents for hardware, software, and system design; Propose and initiate quality improvement projects integrating reliability and PMS plans; Evaluate product designs and perform root cause analysis on quality deficiencies; Validate essential design inputs including usability, reliability, performance, manufacturability, and safety; Support quality audits and inspections; Apply continuous improvement techniques to enhance quality practices.
Seniority
Mid-level to Senior, hands-on IC