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Test Assembler

1 month ago

San Jose, United States MILLENNIUMSOFT Full time

Position : Test Assembler

Location : San Jose, CA

Duration : 12 Months Contract

Total Hours/week :40.00

2nd shift

2nd shift hours 2:30pm start.

Description:

  • Conducts production testing of assembled flow cytometers and related medical device products.
  • May integrate systems and conduct a variety of electronic, mechanical, optical, fluidic and electromechanical activities on systems, subassemblies, and parts to ensure unit functions according to specifications.
  • Will be expected to perform system level and subassembly level troubleshooting to determine root cause, and implement correction of assembly or material defects.
  • Responsible for producing quality products on schedule.
  • Typically works on assignments that moderately difficult, applies detailed technical knowledge.
  • Generally receives some instruction, uses independent judgment for most activities and employs a high degree of initiative.
  • Must be able to work in a team oriented atmosphere with assemblers, technicians, QA personnel, and engineers, completing tasks and communicating effectively, both orally and in writing.

Roles 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.

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: DVMs, 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