Test Technician, Instrument - Katalyst Healthcares & Life Sciences
San Jose, CA 95131
About the Job
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.
- Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.
- Participates as required in training on regulatory issues affecting own area of work.
- Brings regulatory compliance questions/issues to the attention of management.
- Follows BDIS Environmental, Health and Safety (EH&S) policies and procedures.
- Takes responsibility for safety in immediate work area. Participates in EH&S programs.
- Notifies supervisors of all observed hazardous conditions or unsafe work practices.
- May provide recommendations on maintaining the safety of the work environment.
- Other duties may be assigned.
- Requires an Associate's degree (A.S.) or equivalent from two-year college or technical school
- 3+ years 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. 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
- 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
Source : Katalyst Healthcares & Life Sciences