Manufacturing Engineer II

Evaluate current console manufacturing practices and identify those needing improvement. Lead operations to increase production capacity and implement new efficient processes. Analyze and design sequence of operations and workflow to improve efficiency and establish methods for maximum utilization of production facilities and personnel. Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events. Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc. Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity. Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues related to yield, quality, and throughput. Leads scaling up processes from development to full scale manufacturing. Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers. Creates/Updates manufacturing instructions, routings, bills of materials and SOPs and performs training when required. Engineering degree desired or equivalent experience in related job field Proficient in CAD software, preferably SolidWorks. Familiarity with statistical analysis of raw data Proficient in Risk Management according to ISO 14971. 2 yrs biomedical product or medical device development experience. Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus. Proficiency in Minitab Hands-on experience managing suppliers and/or contract manufacturers a plus.