Responsibilities: To ensure corporation's software applications and equipment validating/qualifying to specifications. Submit specification, protocol and report for approvals and documentation control via a Change Request Monitors operations with an eye toward improving productivity and efficiency. Provide all necessary support to OT systems to ensure that all operating technologies are available, maintained, upgraded, and improved. OTE will also be involved in measuring and monitoring quality, integrity and accessibility of real-time information for both monitoring and control including regulatory data compliance. Designs efficient production processes and workflows using technology base foundation. Facilitate sessions around current state processes and define future state processes with monitoring systems in place. Evaluates data to implement technological improvements in production processes. Prepares critical spare part inventory analysis and register them to address production needs and cost optimization. Generates process documentation and reports. Ability to lead and manage cross-functional teams. Strong written and verbal communication skills are necessary for an Engineer. They must be aware of a business's needs while making technical recommendations understandable. Collaborate with other departments and stakeholders to ensure that the solutions align with the organization's overall goals and objectives. Create SOPs, work instructions, process mapping, flowchart, control plan policies, reports, etc. Drives the Area Improvement Team Meeting to deliver pre-determined goals. Requirements: BSc in Industrial Engineering or related field such as manufacturing or mechanical engineering, required. Knowledge of shop floor operation, processes, and standards in the field or medical device industry is added value. 3-5 years relevant work experience in a medical device manufacturing environment Project management skills Manage CI project and conduct assessment for shop – floor. Equipment spare part management experience Operational technology knowledge - software program and process Experience with lean manufacturing principles and continuous improvement methodologies Experience using System Applications and Products (SAP) software, MES, PIMS & ( machine automation system if applicable ) Experience conducting operational critical analysis
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