Manufacturing Technician Job at Elixir Medical Corporation, Milpitas, CA

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  • Elixir Medical Corporation
  • Milpitas, CA

Job Description

MAJOR DUTIES AND RESPONSIBILITIES

Responsibilities will include, but not be limited to:

  • Manufacture commercial, prototype, pre-clinical and clinical units in a Cleanroom Environment. Includes stent preparation, cleaning, and coating, catheter preparation and stent mounting, device inspection, and packaging
  • Operate computer-controlled machinery
  • Complete manufacturing documentation such as Lot History Records (LHR) in compliance with Good Documentation Practices (GDP)
  • Perform preventive maintenance as required for production equipment
  • Organize and assemble materials and product shipments to support commercial and development programs
  • Inspect/test components and assemblies as part of in-process inspection
  • Maintain work area cleanliness and compliance with various safety, fire, and hazmat guidelines
  • Execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture
  • Maintain compliance with all document and procedure training requirements

QUALIFICATIONS

Experience

  • High School diploma
  • Minimum two years' experience as a technician in the medical device industry in a Cleanroom Environment
  • Experience with manufacture and mechanical testing of product
  • Experience with GDP-compliant manufacturing documentation
  • Ability to follow established written procedures with minimum supervision
  • Good oral communication skills
  • Basic computer skills
  • Ability to lift, move and carry up to 10 lbs.

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