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Process Development Engineer

Company: Modis
Location: Bloomington
Posted on: November 22, 2021

Job Description:

A Direct Hire Process Development Engineer position in Bloomington, Indiana is available courtesy of Modis Engineering. This position offers full benefits (medical, dental, and vision), generous PTO, matching 401K, and more. The Process Development Engineer is responsible for the designing and optimizing of processes required to manufacture new medical devices. Identify and evaluate innovative processing options based on product attributes for products, including evaluation based on technical and economic feasibility. Execute cost-effective systems in order to enhance the speed and quality of processing, and ensure produced items comply with government regulations and industry standards. Must be an US Citizen or current Green Card Holder.
Job Responsibilities:

  • Collaborate in a team of engineers focused on design, development, and implementation of new processes (within facilities and/or with third party suppliers) required for the manufacture of new device designs
  • Execute methods needed for efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development)
  • Ensure that a risk based approach is applied during the development implementation and validation of all processes
  • Ensuring that the principles of Design for Manufacture, and Lean manufacturing are central to the R&D process and designs
  • Liaise with production engineering for process engineering layout plans and implementation in relation to new processes and production lines
  • Responsible for process documentation (PFMEA's, Production Instructions, Drawings etc.) associated with new products
  • Collaborate with other R&D teams, Operations, and Production engineering to ensure the effective completion of all activities associated with an R&D Engineering project / objective
  • Compare costs and benefits when choosing product in-house or supplier selection
  • Design and optimize process and process equipment for large and small scale manufacturing
  • Ability to complete projects within specific time lines and meeting performance expectations
  • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
    • Bachelor's or 5 years experience with Master's or 3 years with PhD
    • Strong knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
    • Strong knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards
    • Proficient in Microsoft Word/Excel/Outlook
      Physical Requirements:
      • Works under general office environmental conditions.
      • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
      • Frequently required to stand, walk, and communicate.
      • Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
        **Qualified candidates must be legally authorized to be employed in the United States. This position does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**
        If you are interested in this Process Development Engineer in Bloomington, IN then please click APPLY NOW. If you have questions about the position, please contact Erica Goben at .

Keywords: Modis, Bloomington , Process Development Engineer, Engineering , Bloomington, Indiana

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