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Assembler 2

5 months ago

San Mateo, United States Route 92 Medical Inc Full time
Job DescriptionJob 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