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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
Job Responsibility:
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
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)
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
Requirements:
Min educational requirement should be AS in electronics
Some experience in Testing mechanicals (i.e. electronics, lasers)
Some experience in manufacturing work setting
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
Nice to have:
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