Responsibilities of Design QE include the following: Review/Approval of Design Characterization, Design Planning, Design Input, Design Output, Design Verification and Validation, Operational Qualification, Performance Qualification, Risk Management, Labeling Development, Competitive Testing, Design Transfer and Launch Planning, Design History File (DHF) verification, as well as new product supplier quality engineering responsibilities, including Supplier Quality Agreements and Supplied Item/process qualifications. Responsibilities of NBD include Supplier Quality Agreements, Applicable Design Control Deliverables determination, Supply Chain and Launch Planning, Finished Device Qualification and Direct Ship Strategy, as applicable.