Instrument Test Technician Job at Medical Device Company, San Jose, CA

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  • Medical Device Company
  • San Jose, CA

Job Description

Roles & Responsibilities

  • DUTIES AND RESPONSIBILITIES
  • Performs instrument optimization functions after final assembly: laser alignment, pressure adjustments, electrical adjustments, etc.
  • Performs final production testing and inspection to ensure products meet performance specifications and standards.
  • Analyzes test results on defective units to determine root cause of failure.
  • Replaces or repairs defective components or assemblies, processes appropriate paperwork, may return unit to assembly for repair.
  • Compares test results with specifications and records test data and plots test results. Generates required documentation to complete the Device History Record (DHR)
  • Analyzes test results on defective units to determine root cause of failure. Frequently requires engineering support to resolve complex and unique problems.
  • Must be able to read and understand: detailed test instructions, assembly instructions, work orders, test results, Bills of Materials, Standard Operation Procedures, and all other documentation used to control our products and processes.
  • Confers with engineers, technicians, production personnel, and others regarding testing procedures and results and to resolve problems. Determines, develops and documents troubleshooting techniques.
  • Expected to provide feedback on production and test methods, product design issues, continuously strives to improve product quality and operational efficiency
  • Will provide support to project teams whose objectives may be: quality improvement, cost reduction, cycle time reduction, reliability improvement, increase operational efficiency, or new product introduction.
  • Assists in creating and updating process and product documentation.
  • Must have the ability to create and maintain productive working relationships within the work team and with other functions. Collaborates with peers to achieve shared departmental goals.
  • Collects and documents key measurements and data. Reviews metrics on a regular basis and strives to improve individual and group performance.
  • Keep work area clean organized and safe
  • Fill out time sheets and all other required paperwork accurately and on time. Keeps training file up to date at all times.
  • Other duties may be assigned.

Experience Required

  • 3+ years related experience in a high tech, manufacturing environment
    Experience working in a medical device manufacturing organization
    Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry

Skills & Certifications

  • MINIMUM QUALIFICATIONS
    KNOWLEDGE AND SKILLS
  • Ability to effectively communicate information and respond to questions both verbally and in writing.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
  • Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs on a daily basis
  • Experienced in the use of: DVM’s, Oscilloscope and general test equipment,
  • Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS
  • Must be willing to be trained in other areas of production where the skill level requirements may be lower
  • Knowledge and adherence to safety procedures and programs
  • Exposure to ISO 9000 and cGMP 21 CFR part 820

Eligibilities & qualifications

  • Must have: Associate's degree (A.S.) or equivalent from two-year college or technical school
  • EDUCATION AND EXPERIENCE
  • Associate's degree (A.S.) or equivalent from two-year college or technical school
  • 3+ years related experience in a high tech, manufacturing environment
  • Experience working in a medical device manufacturing organization
  • Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry
  • Extensive knowledge of PC’s and networking environments
  • Strong experience with Excel, Visio, Power Point
  • Strong knowledge of ISO 9000 and cGMP 21 CFR part 820
  • Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)
  • Strong experience with Logic Analyzer and Oscilloscope

Job Tags

Full time,

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