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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