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Prototype, assemble and iterate design concepts using rapid-cycle feedback.Execute design verification and validation testing, test method development/validation and process development/validation with minimal supervision.Complete documentation of data (test methods) and prepare written reports (drawings, protocols, reports, manufacturing instructions) that contribute to the Design History File while assuring accuracy and completeness.Drive root-cause …
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Prototype, assemble and iterate design concepts using rapid-cycle feedback.Execute design verification and validation testing, test method development/validation and process development/validation with minimal supervision.Complete documentation of data (test methods) and prepare written reports (drawings, protocols, reports, manufacturing instructions) that contribute to the Design History File while assuring accuracy and completeness.Drive root-cause …
Responsible for overall Design Quality process to ensure that company design control projects comply with internal design control and risk management procedures in accordance with FDA, and ISOLead cross functional teams to implement and periodically review hazard analyses, risk assessment and other risk management processesProvide guidance to project team members …