Essential Duties and Responsibilities Provides support to new business development relating to manufacturing matters as needed Identifies anticipated manufacturing, facility, environmental, and equipment needs Identifies known or possible manufacturing, health, safety and environmental risks Provides manufacturing cost estimates including labor, input on design (DFM)and required capital equipment Reviews program information/customer specifications including tooling requirements and design to understand product intent, functionality and test requirements Defines line labor, packaging and material supply requirements, as well as manufacturing lead times Drafts plans for manufacturing space and utility requirements Develops and maintains Process Flow Diagram and Control Plan Develops production line, work instructions and assists with training personnel Ensures all ISO procedures are followed within the work cell/production line Ensures GMP standards are followed at all times as required Executes validation protocols to support production lines as required Assist ADC/Tooling Engineers with tooling design review Performs incoming tool inspection (IQ) and drives tool corrections as necessary Ensures all equipment needed to manufacture is available, installed and qualified and if procurement is required, provides specifications Ensures that all equipment or process specifications and methodologies are documented Provides capacity and yield loss analysis Executes Installation Qualification(IQ),Operational Qualifications (OQ) and Performance Qualifications (PQ) when required Conducts samplings and capability studies as required Provides continuous manufacturing engineering support through program end of life Seeks continuous improvements to optimize manufacturing operations by identifying opportunities to reduce production costs and to achieve gains in quality and productivity Provides recommendations/input with the design, building and implementation of new fixtures and tooling to support manufacturing operations Develops and maintain a preventative maintenance program for all tooling required to manufacture product Provides support to other departments to set and achieve program goals to maintain Total Customer Satisfaction Generates and maintains program-related documents including bill of material changes, process changes, updated work instructions, routings/travelers, nonconforming material reports and tooling damage reports Conducts meetings as needed to drive resolution of daily production and quality issues Supports QBR's with customers and provide/present manufacturing related matters Performs all assigned activity in a timely manner Works with co-workers and customers in a safe, professional, and cooperative manner Frequent domestic and rare international travel required Other duties as assigned
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Job Type
Full-time
Career Level
Mid Level
Industry
Plastics and Rubber Products Manufacturing
Number of Employees
1,001-5,000 employees