Manufacturing Process Engineer

Position: Manufacturing Process Engineer Type: Contract Location: Warsaw, IN 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 Top Skills: DFMEA, PFMEA, DFMA, FAI, Supplier OQ, DOE, CAPA, GD&T, Windchill, Tooling, MFG Process Roles & Responsibilities: Mechanical Engineering with 4 years' experience in manufacturing process and operations. Support the attainment of key business metrics through the provision of engineering support for the 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 and develop tools, fixtures, gauges, and special equipment for manufacturing operations in conjunction with Toolroom technicians and outside vendors. Develop stable and capable manufacturing processes through a structured process development approach. Perform scrap and cost analysis based on evaluation of the 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, Clients, and 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: analyzed supplier data, authored protocols and coordinated test specimens, and updated material specifications

Created: 2026-03-10