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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