Validates computer automated controls systems (PLC/HMI) for medical device manufacturing equipment in accordance with GAMP5 standards.Prepare System Design Specification per Statement of Requirements (SOR), System Requirement Specification (SRS) and P&ID specifications.Prepare engineering submittals per proposal and P&ID specifications.Verify that programmers develop PLC/HMI software per design specifications.

• 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.• Advised management on new 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.• Wrote 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 Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FD

• Develop, set-up, maintain & validate manufacturing equipment and processes for the production of FDA approved medical devices • Acts as project manager for projects involving process improvements.• Validate proprietary PLC programming utilizing Kaye® Validator 2000 and 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 are capable of producing parts, assemblies and finished products that meet specifications.• Research new materials to improve product performance and reduce manufacturing costs.• 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 create and revise controlled engineering documentation

• 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.

• Develop, set-up, maintain & validate processes for the production of 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 are capable of producing 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