Manufacturing Process Engineer

1 week ago

Warsaw, United States Omni Inclusive Full time

*Job Summary:
• Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved.
• Mechanical Engineering with 4 years' experience in manufacturing process and operations.
• Medical domain experience

*Roles & Responsibilities:
• Mechanical Engineering with 4 years' experience in manufacturing process and operations.
• Support attainment of key business metrics through the provision of engineering support for value stream process.
• Elimination of safety and quality risks in the process through the delivery of robust engineering solutions.
• Machinery maintenance system support activities for equipment and fixtures.
• Manage costs through the delivery of scrap, reprocessing and consumable reduction projects.
• Modify & Develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors.
• Develop stable and capable manufacturing process through a structured process development approach.
• Perform scrap and cost analysis based on evaluation of manufacturing process for minimizing waste and maximizing production.
• Ensure all process development, validation (IQ, OQ, PQ) etc. is managed in accordance with the Quality management system (QMS).
• Perform Risk Assessment on the process of development to highlight potential failure modes and evaluate identified risks using PFMEA.
• Preparation of all relevant manufacturing specifications.
• Competent in validation requirements for new consumables/materials and process changes.
• Update and maintenance of manufacturing specifications for process steps.
• Ensure timely closure of quality actions such as Audit Actions, Client's, CAPA's.
• Ensure all process development, validation, etc, is managed in accordance with the Quality management system
• Personal computer software - Windows: word processing, project planning, presentation, e-mail.
• Implemented laboratory controls in the polymer lab based on internal regulatory compliance standards.
• Materials R&D SME/DRI for material supplier validations: analysed supplier data, authored protocols and coordinated test specimens, and updated material specifications

Top Skills:
DFMEA, PFMEA, DFMA, FAI, Supplier OQ, DOE, CAPA , GD&T, Windchill , Tooling, MFG Process

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