Descripción del Trabajo
The automation engineer supports operations, engineering, and program management, including:
· coordination of planning
· resource management
· progress reporting; and
· technical leadership for customer manufacturing programs.
The automation engineer focuses particularly on plant systems and automated assembly equipment, while ensuring the applicable technical, quality, and safety requirements of the site are being met.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Provide input and oversight for the development and review of assembly automation and systems, for medical device manufacturing.
· Develops requirement specifications, system concepts, and machine layouts.
· Provide engineering oversight of equipment installation, as well as handoff to production, within the prescribed timeline and budget.
· Facilitate communication between departments, by conducting meetings, and providing status updates.
· Lead continuous improvement (CI) projects on existing manufacturing equipment to achieve efficiency, quality, and/or cost improvements.
· Serves as technical interface with customers, as designated.
· Work with manufacturing to trouble-shoot problems, upgrades, retrofits, set-ups, methods development, and the development of process parameters.
· Conduct engineering studies and design other testing requirements, as needed.
· Perform equipment validation/process testing, as needed.
· Engage in procurement, cost tracking, and budget forecasting for equipment projects.
· Develop operating procedures (SOP’s), maintenance instructions, and training content for equipment.
· Perform sustaining/reliability engineering within the manufacturing operation, as needed.
· Contribute to process development, root cause analysis and systematic problem solving.
· Support applicable safety and quality standards.
· Thorough understanding of engineering principals, tools and processes.
· Ability to interpret mechanical drawings, electrical schematics, and controls systems diagrams, in order to test and troubleshoot automated equipment.
· Knowledge of cGMP principals, to include validation and documentation requirements.
· Knowledge of equipment and facility safety standards, as related to the engineering role.
· General knowledge of controls systems and assembly processes, as related to the manufacturing/equipment engineering role.
· Computer Aided Drawing (CAD) software proficiency, preferred.
· Understanding of basic statistical analysis tools & techniques.
· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
EDUCATION AND EXPERIENCE REQUIREMENTS
· BS, Engineering, Science, or equivalent.
· 5+ Years of related Engineering experience, or an equivalent combination of education, training &/or experience.
· Experience as project lead for a new product, process, or equipment implementation within a highly regulated manufacturing environment.
· Experience with the troubleshooting &/or programming of control systems, including PLC, preferred.
· Technical writing experience, including protocols and procedures, preferred