Create and improve manufacturing processes for the product by optimizing them to ensure efficiency, safety, and cost-effectiveness. Responsible for developing and implementing technical manuals, SOPs, MPIs (manufacturing process instructions), PMP (preventative maintenance procedure), and Quality Management Systems (QMS) following the ISO 13485 standards, 21 CFR Part 820, cGMP compliance, and other regulatory standards. Define equipment maintenance requirements, identify root causes of equipment failures and develop hands-on maintenance skills. Works with other engineering stakeholders and customers on problem solving and continuous improvement to the design of equipment and products and develop corrective and preventive action plans. Analyzes and designs layout of equipment and workspace for maximum efficiency. Engage in Engineering studies using Design of Experiment (DOE) to determine the optimal process parameters of manufacturing assembly and processing equipment. Confers with production group concerning product design and tooling to ensure efficient production methods. Coordinates with customers to determine product specifications and design changes and responds to customer requests. Confers with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes. Applies statistical methods to estimate future manufacturing requirements and potential. Provides support in finding root cause analysis, corrective and preventive plan implementation to ensure compliance with regulations and internal specifications.
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