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    Manufacturing Engineer - Foxborough, United States - Connected Systems Partners

    Connected Systems Partners
    Connected Systems Partners Foxborough, United States

    1 week ago

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    Description

    Job Description

    Job Description

    The Manufacturing Engineer collaborates with team members to devise, enact, and sustain manufacturing procedures. This entails crafting Process Failure Mode and Effects Analysis (PFMEA), Process Flow Diagrams, Manufacturing Cells, and Line Layouts, as well as formulating Process Routers, Equipment Qualification and Process Validation Protocols, Standard Operating Procedures, and Work Instructions. They also enforce lean manufacturing principles to enhance throughput, quality, and continuous improvement.

    Responsibilities:

    • Design processes, specify equipment, develop work instructions, conduct validation (IQ, OQ, PQ), and train production staff.
    • Create, validate, and deploy automated, semi-automated, and manual assembly and test equipment and tooling for disposable product manufacturing, ensuring proper documentation, calibration, and preventative maintenance control.
    • Engage in FMEA activities to identify and rectify process deficiencies effectively.
    • Collaborate with Design Engineers and Quality Assurance to ensure products are designed for ease of manufacturing and compliance with performance, cost, and quality standards.
    • Coordinate with Quality Assurance and Research and Development to uphold an approved internal Quality System meeting FDA QSR and ISO 13485 requirements.
    • Aid in pilot production of various products, establishing lean manufacturing cells to enhance throughput and quality.
    • Support product production, including ensuring proper operator training, adherence to production schedules, and accuracy of production documentation. Collaborate with production staff to pinpoint areas for enhancement.
    • Continuously enhance safety, quality, lead-time, productivity, and cost of existing manufacturing processes.
    • Identify root causes of manufacturing process nonconformities using NCMR and CAPA and enact necessary measures to rectify and prevent recurrence.

    Required Skills/Abilities:

    • Proficiency in designing and fabricating electromechanical components and assemblies.
    • Experience with SolidWorks
    • Experience with FDA GMP, QSR, and ISO 13485 guidelines.

    Education and Experience:

    • Bachelor's Degree in Mechanical Engineering, Mechanical Engineering Technology, Manufacturing Engineering, or a related field.
    • 5 to 8 years of experience in medical device manufacturing.
    • Experience in a medical device environment (ISO 13485 and FDA QSR).
    • Six Sigma Black Belt or Lean Certification
    Company DescriptionThe experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups.
    We specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI.
    Since our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams.
    Get Connected

    Company Description

    The experts at Connected Systems Partners, Inc. have decades of successful experience providing technology recruiting and staffing services for Fortune 500 companies to new business start-ups. \r
    We specialize in Embedded Software, Firmware, Hardware/Electrical, QA/test Engineering, Mechanical and Engineering Technicians, in MA, NH, CT and RI.\r
    Since our founding in 2011, Connected Systems Partners has been providing a superior level of service to the technology workforce, looking to advance their careers and organizations looking to add contract, contract to hire, or permanent talent to their teams. \r
    Get Connected
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