The Manufacturing Engineer, 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 supplier 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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