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:
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Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
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Accurately documents record of work on Lot History Record (LHR) and manufacturing forms
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Sets up and maintains workstation; adheres to CER (Controlled Environment Room) requirements
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Operates production equipment such as hot box, laminator and coil winder
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Performs visual inspection and uses basic measuring tools such as caliper and snap gage
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Identifies units that are non-conforming and notifies management
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Provides feedback to management and engineers regarding process and product improvements
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Relies on experience and judgement to plan and accomplish goals [Assembler 4]
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Self-directed, independently manages time and takes initiative to solve problems [Assembler 4]
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Other duties as assigned; available to work overtime as requested
REQUIRED EDUCATION AND SKILLS:
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High school diploma or equivalent
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Ability to read and speak English (i.e., read and understand manufacturing procedures)
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Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements
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Effective communication, interpersonal and team skills
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Able work with minimal supervision and without instruction on routine work. [Assembler 4]
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Excellent attention to detail and organization [Assembler 4]
PREFERRED EXPERIENCE:
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Minimum 3 years of experience in medical device manufacturing, catheter based preferred [Assembler 2]
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Minimum 5 years of experience in medical device manufacturing, catheter based preferred [Assembler 3]
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Minimum of 10 years of experience in medical device manufacturing, catheter experience a must [Assembler 4]
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Understanding of commonly used concepts, practices and procedures within the medical device industry, especially catheter based
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Ability to use microscopes, tweezers, razor blades, pliers and other handheld tools for small parts.
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Proficiency with use of equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer