Manufacturing Process Engineer

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: • 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. • 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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