Instrument Test Technician - Urgent Fill Position

12 Months Contract – Pay rate: $30/hr. on W2

About the Role

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 perform system-level and subassembly-level troubleshooting to determine root cause and implement corrections for assembly or material defects. Responsible for producing quality products on schedule. Typically works on moderately difficult assignments, applying detailed technical knowledge. Generally receives some instruction, uses independent judgment for most activities, and employs a high degree of initiative. Must work in a team-oriented atmosphere with assemblers, technicians, QA personnel, and engineers, completing tasks and communicating effectively both orally and in writing.

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).
• Frequently requires engineering support to resolve complex and unique problems.
• Reads and understands detailed test instructions, assembly instructions, work orders, test results, Bills of Materials, Standard Operating Procedures, and all other documentation used to control products and processes.
• Confers with engineers, technicians, production personnel, and others regarding testing procedures and results to resolve problems.
• Determines, develops, and documents troubleshooting techniques.
• Provides feedback on production and test methods, product design issues, and continuously strives to improve product quality and operational efficiency.
• Supports project teams focused on quality improvement, cost reduction, cycle time reduction, reliability improvement, increased operational efficiency, or new product introduction.
• Assists in creating and updating process and product documentation.
• Creates and maintains 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 regularly and strives to improve individual and group performance.
• Maintains a clean, organized, and safe work area.
• Completes time sheets and all other required paperwork accurately and on time.
• Keeps training file up to date at all times.
• Stays abreast of basic compliance requirements in own area of work and complies with those requirements.
• Participates 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 the 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.
• Performs other duties as assigned.

Requirements

• Associate's degree (A.S.) or equivalent from a two-year college or technical school in a technical field (Electrical, Mechanical, Electronics, or equivalent).
• 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, 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, oscilloscopes, 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.

Qualifications

• 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, PowerPoint.
• 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.

Pay

$30/hr. on W2

Schedule

12 Months Contract