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San Francisco Bay Area, CA

  • Senior Manufacturing Engineer (or Manager)


    Design and develop manufacturing processes, tooling, and fixtures in order to meet daily
    production schedules while enhancing productivity and product quality.


    • Responsible for all aspects of combination product manufacturing engineering.
    • This will include new product transfers, prototype fabrication, process development and process validations.
    • Design and build or acquire production equipment and tooling.
    • Oversee the manufacturing lines; coordinate manufacturing workflow.
    • Includes writing test plans, protocols and reports in conjunction with verification and
    • validation testing, and equipment qualification (IQ/Operational Qualification/Process
    • Performance Qualification).
    • Optimize manufacturing processes and production lines to increase efficiencies and yields in manufacturing.
    • Provide manufacturing engineering support to new product development projects.
    • Train & supervise manufacturing assemblers as required.
    • Oversee outside vendors and supplier as necessary.
    • Establish and maintain a QSR-compliant manufacturing environment.
    • Ensure compliance with all ISO, EN, MDD and FDA regulations and requirements pertaining to manufacturing engineering.
    • Participate in the development of FMEA and other risk assessment documentation.


    • BS in Mechanical or Manufacturing Engineering required.
    • 10+ years experience in the medical device manufacturing field (Class III device and catheter experience required).
    • Strong written and verbal communication skills, including good interpersonal skill.
    • Proficient with Microsoft Office applications and CAD software (SolidWorks preferred).
    • Hands-on attitude with proven track record for efficiently resolving materials, process, equipment, or training issues on production floor.
    • Ability to plan and implement projects from concept to completion.
    • Ability to define problems, collect data, establish facts, draw valid conclusions and implement solutions.


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