Instrument Test Associate II

Instrument Test Associate II

Responsibilities

• Conducts production testing of assembled flow cytometers and related medical device products.
• Integrates systems and conducts a variety of electronic, mechanical, optical, fluidic and electromechanical activities on systems, subassemblies, and parts to ensure unit functions according to specifications.
• Performs system level and subassembly level troubleshooting to determine root cause, and implements correction of assembly or material defects. Responsible for producing quality products on schedule.
• 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.
• Confers with engineers, technicians, production personnel, and others regarding testing procedures and results and to resolve problems. Determines, develops and documents troubleshooting techniques.
• Provides feedback on production and test methods, product design issues, continuously strives to improve product quality and operational efficiency.
• Supports project teams whose objectives may be: quality improvement, cost reduction, cycle time reduction, reliability improvement, increase operational efficiency, or new product introduction.
• Aids in creating and updating process and product documentation.

Qualifications

• 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

• 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.