Manufacturing Engineer Katalyst Healthcares & Life Sciences - 4.0 Pleasanton, CA Job Details Contract 1 day ago Qualifications Customer communication Manufacturing facility experience Medical device manufacturing facility experience Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality systems Biomedical manufacturing processes

Full Job Description Roles & Responsibilities:

Support in Manufacturing process remediation and readiness activities for new product launch. Support Design Transfer deliverables, including tracking and scheduling. Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures. Risk Management updates - PFMEA. Part creation in Windchill. BOM and configuration management. Work with cross functional teams as required, especially with R D, Quality, and Regulatory teams. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control. Previous medical device experience 5+ years of Medical device Manufacturing experience