Develop, implement, and support molding processes used in the manufacturing of complex high-precision medical devices and components. Design cell layouts and optimize processes to maximize efficiency, develop tooling and fixturing, implement verification and validation plans, troubleshoot using six sigma tools, and lead continuous improvement and cost savings initiatives. Design, develop, and optimize molding and manufacturing processes to meet stringent production, quality requirements, and regulatory standards. This includes process verification and validation, and qualifying vendors, suppliers, components, items, and parts. Perform a variety of engineering tasks in the planning and design of tooling, fixturing, processes, and cell layouts. Oversee the specification, selection, installation, operation, and maintenance of equipment and machines in accordance with company policies and procedures. Investigate and resolve issues during the manufacturing process to ensure site safety, quality, delivery, and cost objectives are met, minimizing machine downtime. Develop and introduce process changes. Create engineering change orders and complete all required documentation and system transactions to implement changes and maintain comprehensive process documentation, including work instructions, process parameters, and validation documents. Provide subject matter expertise and support to our High-Performance Work Teams on the production floor. Implement and drive continuous improvement initiatives to enhance process performance and product quality. Work closely with cross-functional teams, including R&D, Quality, and Production, to support new product development and existing product enhancements. Instruct and direct other engineers in designing tools, fixtures, and processes, and provide support for molding operations. Oversee the maintenance and calibration of molding and manufacturing equipment to ensure optimal performance. Interpret drawings and design processes using CAD programs to manufacture medical devices and components. Investigate new equipment and technologies to reduce costs and increase output. Lead projects and ensure all assigned project deadlines and deliverables are met. Prepare reports, maintain files, lists, logs, and complete required paperwork. Interface with internal and external contacts to complete assignments and resolve problems. Perform other related functions as required by management.
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Job Type
Full-time
Career Level
Senior