Automation Engineer, Medical Device Automation Resume Edwin Rice Automation Engineer, Medical Device Automation (260) 555-1847 edwin.rice@example.com linkedin.com/example/edwinrice Fort Wayne, IN 46805 STRENGTHS Controls Troubleshooting When an automated cell failed, traced logic, sensors, and recovery steps until technicians had a clear fix and steadier operation. Inspection Analysis Connected Cognex results with process data in Minitab. That practical review helped separate process variation from inspection issues. Validation Discipline During IQ, OQ, and PQ work, kept evidence, deviations, and acceptance criteria aligned so quality partners could release confidently. Supplier Collaboration Early source code conversations with equipment suppliers exposed recovery gaps before installation. Shared review made startup smoother for everyone. Technical Writing Clear protocols and work instructions gave technicians a common reference. Colleagues often used those records during troubleshooting and training. Project Coordination Balanced testing windows, production needs, and quality reviews across several teams. Frequent communication kept demanding equipment schedules moving. SKILLS PLC programming Machine vision Fanuc Robots Minitab IQ OQ PQ Process validation Equipment qualification Test Methods Source code review Statistical sampling Process monitoring Technical writing Supplier coordination FDA 21 CFR 820 GMP Medical Devices LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 3.9 Years Automation Engineer, Validated Manufacturing Systems at ClearPath Device Manufacturing (1.9 Years) Controls Engineer, Automated Manufacturing at Midwest Precision Products (2 Years) SUMMARY Automation Engineer with four years of experience supporting controls, machine vision, robotics, and validated manufacturing systems in regulated production environments. Programs and troubleshoots Allen Bradley PLCs , Cognex Vision systems , Fanuc Robots, and automated inspection equipment across high volume medical device operations. Executes IQ, OQ, and PQ activities, develops protocols and work instructions, reviews supplier source code, and prepares traceable engineering records for quality review. Uses Minitab, statistical sampling, and process data to investigate weak yield and improve inspection performance without reducing quality standards. Works closely with manufacturing, quality, validation, suppliers, and technicians to coordinate equipment builds, testing, commissioning, and production releases. Practical knowledge of FDA 21 CFR 820 and GMP Medical Device Regulations supports sound decisions under demanding schedules. EXPERIENCE Automation Engineer, Validated Manufacturing Systems ClearPath Device Manufacturing October 2024 - Present Fort Wayne, IN Owns controls support for automated assembly and inspection cells producing regulated disposable medical components. Leads programming, troubleshooting, qualification, supplier review, technical writing , and cross functional release activities. Connects equipment data with quality decisions and production schedules. Maintained Allen Bradley PLCs , Cognex recipes, and Fanuc sequences through documented change practices. Connected vision rejects with process settings in Minitab , restoring stable inspection acceptance. Executed IQ, OQ, and PQ testing with deviations, evidence, criteria, and release rationale. Reviewed supplier PLC and vision source code, closing alarm gaps before factory acceptance . Authored protocols, work instructions , engineering studies , and guides for validated equipment support. Coordinated controls changes with quality, validation, manufacturing, vendors, and production technicians. Controls Engineer, Automated Manufacturing Midwest Precision Products September 2022 - September 2024 Lafayette, IN Supported automated manufacturing cells with Allen Bradley controls, machine vision, industrial robotics, and qualification activities. Progressed from supervised troubleshooting into independent controls modification, equipment recovery, data analysis, supplier startup, and technician knowledge transfer. Supported Allen Bradley PLCs , machine vision , and robotics across automated manufacturing cells. Built PLC logic for sensors, interlocks, alarms, and sequences using controlled backups. Tuned Cognex inspections with production samples and structured challenge testing for reliable results. Applied Minitab sampling analysis to equipment studies and process monitoring decisions. Contributed IQ , OQ, and PQ evidence packages for regulated equipment qualification activities. Supported supplier installation, issue tracking, corrective action checks, and technician handoff. PROJECTS Automated Inspection Yield Study 2024 Partnered with quality and manufacturing peers on a focused inspection study. Minitab analysis linked image results with process settings, giving shared teams a clearer path for stable acceptance and practical process monitoring. Supplier Equipment Readiness Review 2023 Built productive supplier relationships through source code review and startup discussions. Findings around alarms, recovery, and documentation helped commissioning teams address risks before production installation. LEADERSHIP & AWARDS Received recognition for restoring stable Cognex inspection performance through data based troubleshooting and practical parameter refinement. Recognized by engineering and quality partners for clear qualification records, supplier coordination, and dependable production support. Earned positive team feedback for transferring equipment troubleshooting knowledge to technicians during automated cell startup. EDUCATION Bachelor's Degree in Electrical Engineering Purdue University GPA: 4.0 2022 West Lafayette, IN Coursework: Controls engineering, robotics, machine vision, statistical analysis, systems design CERTIFICATIONS Rockwell Automation PLC Programming Certificate 2023 Minitab Statistical Analysis for Process Improvement Certificate 2024 TECHNICAL SKILLS PLC Systems: Allen Bradley PLCs, ladder logic, Rockwell Automation Machine Vision: Cognex Vision systems, inspection recipes, challenge testing Industrial Robotics: Fanuc Robots, robot sequences, recovery routines Validation Methods: IQ, OQ, PQ, equipment qualification Statistical Analysis: Minitab, sampling methods, process capability Medical Regulations: FDA 21 CFR 820, GMP Medical Device Regulations, quality practices Technical Documentation: Protocols, work instructions, engineering studies Controls Engineering: Sensors, interlocks, alarms, sequence controls Supplier Engineering: Source code review, factory acceptance, equipment startup Quality Records: Acceptance criteria, deviations, test evidence Process Monitoring: Yield analysis, inspection monitoring, production data Project Coordination: Schedule management, production windows, competing priorities SKILLS PLC programming Machine vision Fanuc Robots Minitab IQ OQ PQ Process validation Equipment qualification Test Methods Source code review Statistical sampling Process monitoring Technical writing Supplier coordination FDA 21 CFR 820 GMP Medical Devices PROFESSIONAL AFFILIATIONS Collaborates with manufacturing, quality, validation, and supplier teams through shared technical goals and open project communication. Maintains professional relationships across controls and medical device operations, creating dependable channels for issue resolution and knowledge sharing. LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST
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