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Medical Device Startup Opportunity for Senior Manufacturing Engineer

Russell Solutions Group

Medical Device Startup Opportunity for Senior Manufacturing Engineer

San Francisco, CA
Full Time
Paid
  • Responsibilities

    Are you interested in working with a leading startup in medical technology? 

    Our company has an opportunity with award-winning bioelectronic medicine company headquartered in the San Francisco Bay area, is transforming the standard of care for chronic disease. The company’s wearable neuro-modulation therapies utilize electricity as medicine, merging innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, while its vertically integrated commercial model is transforming the delivery of prescription therapies.

     

    The Opportunity

    We’re seeking an experienced Manufacturing Engineer. The role will

    ensure the highest quality products are provided to our customers, and will focus on

    manufacturing, test, packaging, and design for manufacturability. This position reports to

    the VP of Manufacturing & Quality.

     

    Specific Responsibilities also include:

    • Support manufacturing – troubleshoot issues, conduct training, ensure processes are followed and properly documented
    • Work side by side with the manufacturing operators - engage them in continuous improvement
    • Create and modify MPI’s, LHR’s, and WI’s – incorporate feedback from assemblers/techs
    • Identify KPIs, set baselines and establish targets (weekly reporting)
    • Develop and execute process validations, including IQ/OQ/PQ for fixtures and equipment
    • Oversee material tracking, availability, and resource planning
    • Communicate with Customer Success and Shipping to ensure demand is met

      and Durable Medical Equipment is shipped in a timely manner

    • Coordinate with Commercial, Clinical, and Development teams to identify their device needs and incorporate into build plans
    • Collaborate with Supplier Quality Engineer to oversee contract manufacturer and supplier performance
    • Perform other duties as assigned
      • About you:

        We are looking for a Manufacturing Engineer to support operations in a dynamic, fast- paced startup environment, exemplified by:

        • BS Degree in Engineering from an accredited institution
        • 3-4 years related experience
        • Excellent communicator
        • Able to write clear, concise instructions to carry out complex tasks
        • Detail oriented with an ability to effectively prioritize work
        • Experience working in an FDA regulated environment
        • Lean Manufacturing experience preferred
        • Self-directed, able to work effectively in a start-up environment