POSITION SUMMARY: As a Clearn Room Operator you will cross train in a variety of production areas related to medical device assemblies (including all lower level sub-assemblies and accessories). Working in a clean room environment you will use a wide range of equipment, fixtures, gages and hand tools to manufacture assemble and test medical device products.
PRINCIPAL RESPONSIBILITIES: • Follow clean room protocols including good hygiene, gowning, hair net & PPE • Meet or exceed daily production goals • Follow safety regulations and maintain safety awareness • Adhere to policies, work instructions, quality regulations, SOP’s, WI, cGMP’s, GDP’s and FDA guidelines in the effort to manufacture high quality medical devices at all times • Utilize microscopes and magnifiers to complete work instructions • Utilize a variety of hand tools and machinery to complete assigned manufacturing activity • Perform in-process quality inspections to standards • Accurately maintain logs, forms, and paperwork • Crosstrain in different jobs including assembly, testing, and bench assembly as needed • Work collaboratively in a team environment • Train others as required • Participate in continuous improvement activities and Lean initiatives • Support business needs by working overtime on an as-needed basis • Adhere to and ensure compliance of all company guidelines, policies, procedures, and housekeeping standards • Maintain regular attendance
EDUCATION / EXPERIENCE REQUIREMENTS • High School Diploma/Trade School Diploma/GED preferred • Experience using hand tools and manufacturing equipment preferred • Prior manufacturing experience preferred • Medical device experience preferred
SPECIALIZED SKILLS & OTHER REQUIREMENTS: • Demonstrated ability to read and write English • Basic computer skills • Simple shop math • Manual dexterity to handle small parts • Visual acuity • Ability to interpret blueprints preferred
POSITION DESCRIPTION • Ability to use the follow equipment: o Cutter o Inflate/Deflate machine o Laminator o Measuring tools, including but not limited to micrometer, ring gauge, ruler, guide wires o Microscope o Magnifiers PHYSICAL
DEMANDS: Sitting, standing, walking, fingering, feeling, pulling, grasping, repetitive motion, talking, hearing, required to have close visual acuity to assemble small parts, no adverse environmental conditions
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