EFREN ELIAS DUARTE VELA

MES Critical Manufacturing implementation in HLA (High Level Assembly) Production Lines:

• Introduction of the Industry 4.0 project.
• Provided technical assistance to production team when issues arose.
• Supported software validation risk assessment in a regulated environment, ensuring compliance with industry standards and minimizing validation risks.
• Led the discovery and analysis of sustaining production lines, refining gathered data for seamless MES Critical Manufacturing configuration
• Led the digitization of Device History Records (DHR) within the MES system, significantly reducing paper usage, enhancing process traceability, and improving regulatory compliance.
• Developed documentation, diagrams, and specifications to meet project requirements and regulatory standards.
• Optimized manufacturing processes by implementing continuous improvement initiatives and lean methodologies.
• Collaborated with cross-functional teams to optimize plant operations using MES data insights.
• Maintained compliance with industry standards, updating documentation related to the MES as needed for regulatory purposes.
• Assisted in conducting thorough risk assessments when planning new implementations or modifications to existing systems.
• Ensured seamless integration of MES with other factory systems for optimal data flow and communication.
• Served as a key liaison between management, IT, engineering, and production departments to facilitate seamless MES integration into daily workflows.
• Trained new employees on MES operations, increasing their proficiency and reducing the learning curve for effective integration into the team.
• Managed multiple projects simultaneously, prioritizing tasks effectively to meet deadlines without compromising quality.
• Support risk assessment of software validation in regulated industry. Perform routing and requirements configuration in MES.
• Integration of the communication with the documentation system for consultation of work instructions and trainings in the production line.

MES Critical Manufacturing implementation in NPI production lines: Support in the transfer of production lines from San Jose CA working side to side with manufacturing, production, document control and quality departments. Leader of implementation of MES in HLA line of devices for cataract surgeries with 30+ subassemblies

• Provided support in Go-Live during the final phase of Critical Manufacturing implementation in a HLA production line, ensuring a smooth transition and operational stability.
• Participated in User Acceptance Testing (UAT) by designing test cases, protocols, and documentation to ensure system functionality and compliance.
• Served as a key liaison between management, IT, engineering, and production departments to facilitate seamless MES integration into daily workflows.
• Layout: Designing and Modifying
• Self-motivated, with a strong sense of personal responsibility.
• Implemented continuous improvement initiatives, identifying inefficiencies in existing systems and processes.
• Worked effectively in fast-paced environments.
• Skilled at working independently and collaboratively in a team environment.
• Proven ability to learn quickly and adapt to new situations.
• Excellent communication skills, both verbal and written.
• Developed comprehensive user documentation, facilitating easy reference for operators and maintenance staff alike.
• Headcount Reduction in production lines participating in A3 Projects.
• Metric´s for continuous improvement projects: VSM, Standard Work, 5´s, Problem Solving.
• Designed and developed layouts for NPI (New Product Introduction) lines, optimizing workflow and space utilization.

• Develop and prepare visual aids to support processes and presentations.
• Collect and analyze production data from production lines for process optimization.
• Conduct detailed time studies to improve efficiency and workflow.
• Optimize line balancing by distributing work efficiently across production lines.
• Lead and implement continuous improvement projects using A3 problem-solving methodologies.
• Establish and maintain workplace organization and efficiency through 5S implementation.
• Assess and improve workplace ergonomics to enhance safety and productivity.
• Create, modify, and enhance layout design and optimization to improve workflow and space utilization.
• Develop and update work instructions to standardize processes.
• Utilize software tools such as AutoCAD to design and update layouts and technical drawings, Visio to create process flow charts for production planning and analysis, and DraftSight to develop technical drawings for manufacturing and process improvement.
• Define and optimize floor delimitation to ensure efficient operations.
• Develop and refine value stream mapping (VSM) diagrams to analyze and improve processes.
• Hold a Lean Bronze Certification, demonstrating expertise in Lean principles and methodologies.
• Implement headcount optimization strategies to improve workforce allocation in production lines.
• Utilize continuous improvement metrics such as VSM, Standard Work, 5S, and Problem-Solving to enhance processes.