Instrument Test Technician 2

TechDigital Group; Milpitas (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

TechDigital Group is seeking a Production Test Technician in Milpitas, CA to perform instrument optimization, final testing, and defect analysis on medical device products. You will work with engineers, QA, and production staff to troubleshoot, document outcomes, and improve processes.

Strong communication, math, and hands-on test skills are essential. The role requires an Associate's degree and 3+ years in a high-tech manufacturing setting, preferably with optical and electronic systems, and

Qualifications

• Associate's degree (A.S.) or equivalent required; typically two-year college/technical school.
• 3+ years of related experience in high tech manufacturing.
• Experience in a medical device manufacturing environment is preferred.
• Experience testing and troubleshooting laser-based optical systems, fluidic systems, and digital/analog circuitry.
• Strong knowledge of ISO 9000 and cGMP 21 CFR part 820.
• Proficient in Excel, Visio, and PowerPoint.

Responsibilities

• Perform instrument optimization after final assembly, including laser alignment and electrical adjustments.
• Conduct final production testing and inspection to ensure specifications are met.
• Analyze test results to determine root cause and implement repairs.
• Document test data and complete Device History Records (DHR).
• Generate documentation and support quality improvement and cost-reduction initiatives.
• Maintain safe, clean work environment and accurate timekeeping.

Skills

Communication skills

Mathematical concepts

Geometry concepts

Manual dexterity

LEAN & Six Sigma knowledge

Technical documentation comprehension

Team collaboration

Root cause analysis

Education

Associate's degree (A.S.) or equivalent

Tools

Oscilloscope

DVMs

Test equipment

Excel

Visio

PowerPoint

PC/MAC basics

Job description

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

DUTIES AND 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.
  • Other duties may be assigned.

KNOWLEDGE AND SKILLS

• 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

EDUCATION AND EXPERIENCE

• Associate's degree (A.S.) or equivalent from two-year college or technical school
• 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 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