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San Mateo

    Assembler 2 - San Mateo, United States - Route 92 Medical Inc

    Route 92 Medical Inc
    Route 92 Medical Inc San Mateo, United States

    1 week ago

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    Description

    Job Description

    Job Description

    PURPOSE OF JOB:

    Assemblers performs assembly, inspection, and test steps to manufacture complex catheter based medical devices per documented procedure in a timely manner.

    RESPONSIBILITIES:

    • Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
    • Accurately documents record of work on Lot History Record (LHR) and manufacturing forms
    • Sets up and maintains workstation; adheres to CER (Controlled Environment Room) requirements
    • Operates production equipment such as hot box, laminator and coil winder
    • Performs visual inspection and uses basic measuring tools such as caliper and snap gage
    • Identifies units that are non-conforming and notifies management
    • Provides feedback to management and engineers regarding process and product improvements
    • Relies on experience and judgement to plan and accomplish goals [Assembler 4]
    • Self-directed, independently manages time and takes initiative to solve problems [Assembler 4]
    • Other duties as assigned; available to work overtime as requested

    REQUIRED EDUCATION AND SKILLS:

    • High school diploma or equivalent
    • Ability to read and speak English (i.e., read and understand manufacturing procedures)
    • Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements
    • Effective communication, interpersonal and team skills
    • Able work with minimal supervision and without instruction on routine work. [Assembler 4]
    • Excellent attention to detail and organization [Assembler 4]

    PREFERRED EXPERIENCE:

    • Minimum 3 years of experience in medical device manufacturing, catheter based preferred [Assembler 2]
    • Minimum 5 years of experience in medical device manufacturing, catheter based preferred [Assembler 3]
    • Minimum of 10 years of experience in medical device manufacturing, catheter experience a must [Assembler 4]
    • Understanding of commonly used concepts, practices and procedures within the medical device industry, especially catheter based
    • Ability to use microscopes, tweezers, razor blades, pliers and other handheld tools for small parts.
    • Proficiency with use of equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer
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