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San Francisco Bay Area, CA

  • Manufacturing Engineer (tool & fixture design)

    ALAMEDA, CA

    As a member of the Manufacturing Engineering group, you will be called upon to solve complex problems and implement innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes. Working cross-functionally with engineering groups across the company, as well as with Production, Quality Control and Quality Assurance, you will resolve problems encountered on the production floor and throughout the business, and will apply your engineering knowledge and creativity to implement adaptations and modifications to the production line and to quality systems.

    What You’ll Work On

    • Optimize production processes by designing fixtures, acquiring off-the-shelf tooling and equipment, and implementing new fixturing on the production line.
    • Perform equipment qualifications.
    • Test processes, equipment, raw materials, and products, and perform process validations.
    • Execute detailed root cause analyses and recommend vetted solutions.
    • Communicate and explain problems and solutions to all levels, from production assemblers to senior management.
    • Make recommendations and author protocols based on test results.
    • Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.
    • Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.
    • Participate in project planning and scheduling.
    • Support production by training assembler and quality control technicians, creating and maintaining product and process documentation, and implementing process improvements that increase yield, efficiency, and/or throughput.

    What You Bring

    • A passion for tackling and solving technical problems.
    • The ability to communicate complex issues in a clear, compelling manner, both orally and in writing.
    • At least three years of engineering experience in a manufacturing environment. Medical device experience strongly preferred.
    • The ideal candidate will also have catheter engineering experience.
    • Also desired are knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes.
    • BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline.

     


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