| Job Summary: |
| Develops new or modified production processes and formulations, defines processing or handling equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacture, fabrication, and evaluation of products. Involvement may begin at any step from pilot plant to full-scale manufacturing. Coordinates design requirement review with appropriate engineering, product development, and manufacturing personnel to ensure compatibility of processing methods. Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. Conceives and plans projects involving definition and selection of new concepts, technologies, and manufacturing systems. |
| Essential Job Functions: |
| · Develop & implement lubrication processes for glass and plastic syringes, including needle siliconization, washing processes for glass ready to fill syringes, processes for batch siliconizing rubber parts and processes for high speed gluing of plastics to glass.· Develop processes and manufacturing technologies for new safety medical devices together with product development. Identify and implement new cost effective manufacturing concepts to increase productivity and reduce overall product costs. Create project plans, Work Instructions, Equipment Requirements, etc. for new manufacturing systems.· Develop, justify and manage capital engineering projects to support new products, as well as increase productivity on existing products.· Work on cross-functional teams and R&D personnel during the concept phase of new products to incorporate manufacturability and assembly features into the product to reduce overall product costs and transfer new products from the development into the manufacturing environment.· Create, justify and implement manufacturing strategies that support automation concepts which lead toward efficient “Lights Out” production.· Manages the transfer of technology to offsite subcontractors establishing qualification and validation of manufacturing processes within their facility. Will also generate cost estimates, R.O.I., and comparative studies in determining the best fit for manufacture methodology.· Support Senior Management, immediate supervisor, and peers by anticipating problems, providing input on solutions, reacting productively to change and handling other tasks as assigned. |
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| Education/Experience Required: |
| Bachelor’s Degree in Chemical Engineering or Mechanical Engineering; a Master’s degree is preferred. A minimum of 7 years of engineering experience in fluid process technology is required. Must have good analytical skills and the ability to apply principles of engineering thinking to a wide range of practical problems and understand nonverbal symbolism (formulas, scientific equations, graphs etc.).Must be able to implement Statistical Process Control tools, such as DOE and six sigma.Experience in medical device or pharmaceutical manufacturing requirements (i.e. FDA. GMP, ISO) is preferred. Direct experience in the manufacture of class I and class II medical devices and ISO 13485 is preferred. Must have the ability to use a variety of abstract and concrete variables, including the ability to read, analyze and interpret scientific and technical journals and identify and establish qualified mold and molded component suppliers to support manufacturing objectives. Must be PC literate in Microsoft Office applications including Microsoft Project, Word and EXCEL. Experience in automated production of disposable, molded plastic or glass medical devices, such as syringes, is highly desirable. |
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