Instrument Test Associate II
About The Position
The Instrument Test Associate II will conduct production testing of assembled flow cytometers and related medical device products. This role may involve integrating systems and performing various electronic, mechanical, optical, fluidic, and electromechanical activities on systems, subassemblies, and parts to ensure unit functions according to specifications. The associate will be expected to perform system-level and subassembly-level troubleshooting to determine root causes and implement corrections for assembly or material defects. This position is responsible for producing quality products on schedule and typically works on assignments that require detailed technical knowledge, applying independent judgment and initiative. Collaboration within a team-oriented atmosphere with assemblers, technicians, QA personnel, and engineers is essential, requiring effective oral and written communication.
Requirements
- 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
- 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
- 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.
- Associate's degree (A.S.) or equivalent from two-year college or technical school.
Nice To Haves
- Exposure to ISO 9000 and cGMP 21 CFR part 820
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, and may return units 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.
- 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 on a regular basis and strives to improve individual and group performance.
- Keeps work area clean, organized, and safe.
- Fills 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
