Test Assembler
Summary
Title: | Test Assembler |
---|---|
ID: | 157475 |
Department: | Operations |
Description
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: 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
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