Manufacturing Engineer

3 weeks ago


Addison, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Perform continuous improvements and ongoing support of existing manufacturing lines and process/product development lifecycle. Navigate the complexities of government and industry regulations to include ISO13485 and cGMP (Current Good Manufacturing Practices). ssist in the launching of new products and processes from concept to final release in manufacturing. Utilize DOE (Design of Experiment), QSR (Quality Systems Regulations), and IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification). Understand Risk-based failure mode analysis (PFMEA and PFMECA). Conduct Data Analysis using SPC (Statistical Process Control) principles and Minitab. Coordinate small to medium scale projects, coordinating activities, resources, and project timelines. Utilize Lean and Six Sigma practices to include DMAIC processes and root cause analysis, 5S, scrap reduction and yield improvements. Coordinate various CAPA (Corrective Action /Preventative Action) projects. Supporting software projects to include Microsoft Project.



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