This position requires a dynamic, energetic, self driven, engineer broad technical background. The automation and manufacturing engineer will support the scale up and manufacturing of a high volume disposable medical device. This individual will be responsible for defining system requirements, executing experiments and developing proof of principle systems and prototype equipment. The engineer will develop timelines and provide direct oversight and management of automation suppliers as well as driving the implementation and validation of manufacturing lines for Intuity products. This individual will work closely with product development engineering, quality, materials planning and sourcing in order to ensure manufacturability, achievement of cost targets, and develop processes for optimum manufacturability. This individual will develop documentation (requirement specifications, drawings, qualification and validation reports) to support the automation lines and equipment. The individual will perform troubleshooting and implement process changes that improve manufacturing quality and product performance via activities such as historical data and failure analysis, test design, documentation, and the implementation/validation of equipment and process changes.
Position Description and Responsibilities:
- Define automation needs, develop user requirement specifications and manage automation programs and project schedules.
- Provides expertise in project planning and timeline development & management and will maintain schedules such that timelines are achieved.
- Works with US based and international automation suppliers to deliver high volume manufacturing systems.
- Responsible for preparation and execution of validation protocols and completion of validation reports.
- Implement and manage process improvement and cost reduction programs. Monitor product quality and production rates. Ensure capacity is appropriate for the manufacturing plan.
- Effectively utilize lean manufacturing tools (visual management, 5S, JIT, Kanban) to continuously improve the flow of material, products and information in the factory.
- Assist in product failure investigations and design changes required to improve product reliability and performance.
- As a member of the design team, evaluate and challenge product designs for technical merit, reliability, and manufacturability.
- Manage development transfer activities between R&D, Product development and operations.
- Propose, review and approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements (ISO), Company policies, operating procedures, processes, and task assignments.
- Experience managing and leading large complex cross functional projects involving, electrical, electro-mechanical, optical and software elements.
- Experience with mechatronics or automation engineering including; machine, mechanism and fixture design
- Strong problem solving and analytical skills; experience with use of statistical analysis and design of experiments for product optimization and validation activities
- Experience with lean manufacturing, design for manufacturing, design for test and test implementation
- Proficient in 3D mechanical modeling with SolidWorks
- Excellent organizational, verbal and written communication skills as well as attention to details
- Ability to coach and develop employees and develop effective cross functional relationships
- This position requires interface throughout all levels and functions of the organization; requires a cooperative team-balanced perspective for appropriate output and task outcome
- Experience working in regulated product and manufacturing environments (ISO, FDA, cGMP)
- Minimum of a BS in a related science discipline (mechanical, electrical, manufacturing or process engineering);
- 5+ years experience in manufacturing and automation engineering
- 2+ years in a senior engineering role leading a team or acting as the primary technical interface to a CM.
Travel required 20-30%