| Manufacturing Process Engineer || Warsaw, IN || Onsite at Warsaw, Indiana, USA |
| Email: [email protected] |
| From: Riya, IDC Technologies [email protected] Reply to: [email protected] Role: Manufacturing Process Engineer Location: Warsaw, IN || Onsite Duration: Contract Top Skills: DFMEA, PFMEA, DFMA, FAI, Supplier OQ, DOE, CAPA , GD&T, Windchill , Tooling, MFG Process Additional Details: Medical Device usability standards, FDA Standards, Project Management *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, NCRs, CAPAs. 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 Keywords: rlang |
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| Thu Oct 19 06:28:00 UTC 2023 |