Sr. Design Quality Engineer

Job description

Position Description: Sr. Design Quality Engineer for Covidien, LP (a Medtronic company), Perform Quality engineering activities in support of new product development. Work cross-functionally to review requirements and identify and assess product risks, and mitigation strategies, as well as review protocols and reports to support product validation. Support Systems NPD Quality team in performing engineering analysis to ensure design quality, analyzing system, and sub-system risk, technical writing, resolving high-profile quality issues, and product improvements for robust design. Utilize Medical device design controls, product risk files, and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC), Design for Reliability (DfR) and Design for Manufacturing (DfM). Utilize DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R, ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, Confidence & Tolerance interval analysis and process control. Evaluate products and process risks using d/p Failure Mode, Effects, and Criticality Analysis (FMECA), utilizing ISO 14971. Navigate New Product Development L...