Test Technician, Instrumentation Specialist

4 weeks ago

San Jose, California, United States Katalyst Healthcares and Life Sciences Full time
Job Summary:

At Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Test Technician, Instrumentation Specialist to join our team. As a key member of our production team, you will be responsible for performing instrument optimization functions, final production testing, and inspection to ensure our products meet performance specifications and standards.

Key Responsibilities:
  • Perform instrument optimization functions after final assembly, including laser alignment, pressure adjustments, and electrical adjustments.
  • Conduct final production testing and inspection to ensure products meet performance specifications and standards.
  • Analyze test results on defective units to determine root cause of failure.
  • Replace or repair defective components or assemblies, process appropriate paperwork, and return units to assembly for repair if necessary.
  • Compare test results with specifications, record test data, and plot test results. Generate required documentation to complete the Device History Record (DHR).
  • Analyze test results on defective units to determine root cause of failure, frequently requiring engineering support to resolve complex and unique problems.
  • 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.
  • Confer with engineers, technicians, production personnel, and others regarding testing procedures and results, and to resolve problems. Determine, develop, and document troubleshooting techniques.
  • Provide feedback on production and test methods, product design issues, and continuously strive to improve product quality and operational efficiency.
  • Support project teams whose objectives may be quality improvement, cost reduction, cycle time reduction, reliability improvement, increase operational efficiency, or new product introduction.
  • Assist in creating and updating process and product documentation.
  • Maintain productive working relationships within the work team and with other functions, collaborating with peers to achieve shared departmental goals.
  • Collect and document key measurements and data, reviewing metrics on a regular basis and striving to improve individual and group performance.
  • Ensure a clean, organized, and safe work area, and accurately complete time sheets and other required paperwork on time.
  • Comply with regulatory requirements and participate in training on regulatory issues affecting the area of work, bringing questions or issues to the attention of management.
  • Follow BDIS Environmental, Health and Safety (EH&S) policies and procedures, taking responsibility for safety in the immediate work area, participating in EH&S programs, and notifying supervisors of hazardous conditions or unsafe work practices.

Requirements:
  • Requires an Associate's degree (A.S.) or equivalent from a two-year college or technical school.
  • 3+ years of related experience in a high-tech, manufacturing environment.
  • 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, with the ability to reach, bend, and lift 35 pounds on a daily basis.
  • Experience with DVMs, Oscilloscope, and general test equipment.
  • Experienced PC or MAC user, familiar with Word, Excel, Windows, and/or MAC OS.
  • Willingness 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.
  • 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 PCs 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.

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