Description
SUMMARY:The Manufacturing Engineer II is responsible for technically supporting the medical device manufacturing operation. The Manufacturing Engineer II works to support new product design, develop manufacturing processes and prepare for new product transfer. The Manufacturing Engineer II also supports daily production operations and process and product improvement activities.
DUTIES/RESPONSIBILITIES:
*Participate in design reviews for new product design and development; ensure designs meet requirement specifications
*Review all product documentations and ensure design manufacturability
*Design and develop manufacturing plan, processes, testers, fixtures and equipment
*Participate in vendor and supplier qualification processes; ensure capability to meet company's quality standards, technical requirement specifications and supply demand
*Support installation, qualification and validation of new equipment and processes; write and execute feasibilities, protocols/reports and standard operating procedures (SOPs)
*Provide troubleshooting, failure analysis and training for staff
*Create/implement programs for volume demand increases, cost reduction, quality and efficiency improvement
*Resolve technical issues with vendors and suppliers
*Resolve electronic parts obsolescence and Restrictions on Hazardous Substances (RoHS) / Waste of Electrical and Electronic Equipment (WEEE) component engineering issues; drive and coordinate activities to make all active manufactured instruments RoHS/WEEE compliant (Electrical Engineer specific)
*Establish a safe, secure, controlled and efficient operating environment
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