Staff Manufacturing EngineerAtriCure, Inc. has an opening for the Staff Manufacturing Engineer in Mason, OH who is responsible for developing, validating, and maintaining capable and stable manufacturing processes to meet product quality standards/requirements.Duties include:
Ensure continuous improvement in process, cost, quality, and production;
Mentor members of the Manufacturing/Process Engineering Teams;
Support and drive a continuous improvement culture within the PD teams and the operations organization;
Define high level manufacturing system/flow requirements and select appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets;
Collaborate with product design engineers to identify and implement Design for Manufacture/Design for Assembly improvements;
Apply lean manufacturing (Toyota production system) principles to the design of manufacturing processes, facilities layouts, and business processes associated with manufacturing;
Participate in development of product requirements and lead manufacturing risk management activities (Process FMEA, Validation Master Plan, Inspection and Test methods);
Select suppliers for parts and equipment;
Coordinate prototype and pre-production builds;
Specify, design, and manage procurement of equipment, fixtures, and tooling; and
Apply project management best practices to manufacturing engineering projects including development of work breakdown structures, identification of required resources, budgeting and management of required expenses, and daily task and resource management to achieve expected project outcomes.
Anticipated 10% domestic and 5% international travel to AtriCure and supplier sites.
Required:
Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Production Engineering, Biomedical Engineering, or related field (foreign equivalent degree accepted) with 10 years of progressive, post degree experience as a Manufacturing Engineer, Process Engineer, or a closely related role OR a Master’s degree in Industrial Engineering, Mechanical Engineering, Production Engineering, Biomedical Engineering, or related field (foreign equivalent degree accepted) with 8 years of experience as a Manufacturing Engineer, Process Engineer, or a closely related role
8 years of experience in manufacturing process development
5 years of experience in each of the following:
Design for Manufacturing (DFM) & Design for Assembly (DFA); and
Technical data analysis, application of advanced statistical tools/techniques for the process development and validation activities.
3 years of experience in each of the following:
In good manufacturing practices (GMPs) and Good documentation practices (GDPs) in technical writing;
Working for a class II or class III medical device manufacturer;
In process characterization/design of experiments;
Developing manufacturing and project plans and leading projects independently;
In fixturing and gages development;
In defining high level manufacturing system and flow requirements to design a process;
In selecting appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets; and
