Documentation Specialist Manufacturing Engineer

ARNOLD HARRISON

*** ******* **. ************* ** 30044

678-***-****

Summary: Over twenty-five years of experience in the design and manufacturing of medical devices and/or electro-mechanical equipment. Experience developing and executing systems and software validations. This includes the raw development of validation documents - USR, SRS, SDS, DDS, FS, CSV, IQ, OQ, & PQ. Experience with design and implementation of machine guard systems for automation & nuclear medical manufacturing equipment. Knowledge and experience in mechanical/electrical engineering concepts of industrial production machines, process controls, motion control and automation. This includes direct experience with the design and programming of Rockwell, Siemens, and various systems PLC’s, DCS’s, SCADA and HMI’s. Twenty years supervising, training and mentoring production personnel technicians, and engineers. Fifteen years of experience in research and development, either as a technician or an engineer, testing or analyzing materials and equipment for functionality, feasibility, and reliability. Fifteen years designing and developing medical device commercial product, manufacturing processes and equipment with the aid of 2D/3D CAD/CAM - SolidWorks and AutoCAD Inventor. Employs statistical analysis tools to improve equipment productivity and reliability. Manages projects responsible for the procurement of new production equipment or development of proprietary equipment - including the installation, integration, and validation of the equipment.

Sr. Controls System and Validation Engineer April 2013-present IS International Services, LLC, Lawrenceville, Georgia

Senior Validation and controls engineer responsible for Johnson and Johnson Projects in Jacksonville, FL, Cornelia and Athens, Georgia. Generated the CSV documentation for Manufacturing Extension Software (Camstar) and all automated manufacturing equipment for a new medical device manufacturing facility.

Designing hardware and software and perform programming and programming modifications and testing for PLC/HMI programs (utilizing RS Logix 5000 Enterprise, Factory Talk ME, Siemens S7 and TIA Portal), to meet production requirements, facilitating the validation of automated manufacturing equipment and CAMSTAR Manufacturing Execution System (MES) software, designing and implementing safety guarding for automated equipment to be in compliance with Zero Access and SIL Classifications, and analyzing the feasibility of automated processes utilizing data collection and statistical analysis tools and software, i.e. MiniTab.

Sr. Project Engineer April 2011- April 2013 Remington Medical Inc., Alpharetta, GA

Manages OEM projects by interfacing and coordinating between internal and external customers. * Sustains and analyzes existing manual and automated processes. * Develops and implements continuous process improvements. *Modified PLC and HMI programs for injection molding machines to expand their process capabilities while maintaining compliance* Advised management on innovative technology purchases. * Validated new and existing automated equipment in accordance with GAMP5. * Implemented new technologies and processes to expand manufacturing capabilities * Mentored and trained associate engineers, interns, technicians, and equipment operators. * Lead product development efforts of new products. * Authored technical reports and documentation (i.e., Design History, Risk Management, Product Realization Files, Mold Verifications, Product/Process Validations) * Reviewed and approved engineering documentation and change orders. * Perform engineering analysis on proprietary and OEM products * Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Automated Manufacturing Practices (GAMP), Good Documentation Practices (GDP), ISO, and FDA

Manufacturing Engineer July 2005 - April 2011 Theragenics Corporation, Buford, GA

*Develop, set-up, maintain & validate manufacturing equipment and processes to produce FDA approved medical devices * Manages projects involving process improvements. * Designed and built remotely controlled process and test systems required to manufacture radioactive medical devices. *. Specified, built, and programmed controls to remotely monitor and control automated manufacturing equipment (utilizing RS Logix 500 and Automation Direct DirectSOFT) * Validate proprietary PLC programming utilizing various data acquisition tools. * Develop, perform, and document equipment installation/operational and performance protocols * Supervise operators and technicians during prototype, clinical and production builds * Audit internal processes for compliance to GMP, Quality System Regulations for medical devices (21 CFR 820), ISO, and FDA regulations. * Contributes to the mechanical design and development of new products and product improvements utilizing engineering, analytical and statistical tools to develop innovative solutions to design challenges. * Develop CNC programs to fabricate production parts and prototypes. * Designed, and tested product concepts and/or final models for functionality, as well as the ability to meet the product specifications. * Develop tests and employ electronic data acquisition tools to measure and monitor process variables * Specified manufacturing and assembly processes and validated that those processes can produce parts, assemblies and finished products that meet specifications. * Specified manufacturing parts, tools, and equipment for a new product line. * Sourced and qualified vendors to comply with industrial standards - ISO, GMP, FDA, etc. * Employed lean manufacturing methods to reduce unnecessary inventory and operator errors. * Improve existing designs to enhance product performance, quality, and safety. * Provided technical support to manufacturing groups as required. * Utilize AutoCAD, SolidWorks, and MS Office to design, analyze, manage, and document engineering projects.

CAD/Documentation Specialist April 2004 - July 2005 Applied Technical Services, Marietta, GA

* Supervised engineering technicians performing non-destructive testing during boiler and paper mill outages. * Employ AutoCAD and MS Office suite tools analyze, correlate, and present engineering data in reports for the non-destructive testing of power boilers, paper mills and cranes. * Employ programming techniques to automate documentation.

Process Engineer December 2001 - March 2004 Novoste Corporation, Norcross, GA

* Develop, set-up, maintain & validate processes to produce FDA approved medical devices * Supervise operators and technicians during prototype, clinical and production builds * Contributes to the mechanical design and development of new products and product improvements utilizing engineering, analytical and statistical tools to develop innovative solutions to design challenges. * Developed prototypes for performance testing to meet product specifications. * Designed, and tested product concepts and/or final models for functionality, as well as the ability to meet the product specifications. * Develop tests and employ electronic data acquisition tools to measure and monitor process variables * Specified manufacturing and assembly processes and validated that those processes can produce parts, assemblies and finished products that meet specifications. * Investigated new product opportunities; assist in determining the viability, probable cost, and payback to the corporation. * Researched new materials to improve product performance and reduce manufacturing costs. * Improved existing designs to enhance product performance and quality. * Provided technical support to manufacturing groups as required. * Utilize AutoCAD, SolidWorks, Agile & MfgPRO and MS Office to create and revise controlled engineering documentation

Civilian Education: B.S. Information Systems Technology, Herzing College, Atlanta Ga., 2003 A.S. Computer Information Systems, Programming, Herzing College, Atlanta Ga., 2002 Diploma, Industrial Electronics & Robotics, McGraw-Hill Continuing Education, Washington DC, 1998 Brooklyn Technical High School, Brooklyn NY, 1981