The Manufacturing Engineer Senior, External Products will design, develop, and validate manufacturing processes, equipment, and systems to meet manufacturing delivery goals while ensuring product quality, and delivery. This 12-month plus contract position is part of the Sourced Finished Medical Device team and entails driving improvements suppliers of finished medical devices.
Responsibilities • Managing projects which include new production equipment, process improvements, cost reduction initiatives, and new product onboarding while supporting the day to day operation success of assigned key suppliers. • Successfully contributes to both new product development and current product support of suppliers, typically including the following activities: process capability studies, process development, process validation, value improvement projects, protocol / report review and approval, capacity analysis, and process risk reviews. • Review and manage supplier change requests through the Supplier Change Impact Assessment (SCIA) and Change Notice processes. • Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success. • Ability to independently designs and coordinate engineering tests and experiments including Design of Experiments. • Prepares standard reports/documents and presentations to communicate results/recommendations to the technical community or management • Trains and/or provides work direction to operators/technicians at Supplier Sites (OEM and CM suppliers).
Preferred Qualifications: • BS in Engineering from ABET accredited institution • 5 - 8 years of manufacturing experience • Proven organization and execution skills • Proven ability to solve technical problems and implement solutions • Proven leader and team player with the ability to drive tasks / projects to completion • Willing and able to work with engineers and technical staff from a suppliers at a different site. • Strong verbal and written communication skills. • Ability to travel 25% of the time (Including International). Travel typically does not occur over weekends.
Preferred Qualifications: • Experience in the Medical Device field • Experience with Contract Manufacturers (CM) and/or Original Equipment Manufacturers (OEM) • Manufacturing Experience