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Instrument Assembly Associate II

1 month ago

San Jose, United States MILLENNIUMSOFT Full time

Position       : Instrument Assembly Associate II

Location : San Jose, CA

Duration : 12 Months Contract

Start Time : 2:30 PM

End Time : 11:00 PM

Total Hours/week :40.00

Description:

  • Performs electro-mechanical assembly of flow cytometers, sub-assemblies and related medical device products.
  • Follows established methods and procedures in performing, assembly of optical, mechanical, fluidic and electronic components and assemblies.
  • Employs high standards of workmanship to ensure high quality products are produced on schedule.
  • Typically works on assignments that are routine. Understands implications of work, and makes recommendations for improvement.
  • Normally receives instruction on daily work, occasionally uses independent judgment and employs some 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

Justification:

  • To support the production of options for Influx, Aria, Fusion, and Melody.

Responsibilities:

  • Performs instrument assembly by following released procedures
  • Performs in process inspection to ensure products meet specifications and standards.
  • Generates required documentation to complete the Device History Record (DHR)
  • May require engineering support to resolve complex and unique problems.
  • Must be able to read and understand: assembly instructions, work orders, 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 assembly procedures.
  • Expected to provide feedback on production and 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 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 Client 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.

Qualification & Skills:

  • Typically requires a High School diploma
  • 2+ years related experience in a high tech, manufacturing environment
  • Ability to effectively communicate information and respond to questions both verbally and in writing.
  • Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs on a daily basis
  • 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

Desirable Qualifications:

  • A.S. degree, or vocational instruction in electro-mechanical assembly
  • Experience working in a medical device manufacturing organization
  • Experience working in a clean room environment.
  • Experience building: laser based optical systems, fluidic systems, digital and analog circuitry
  • Extensive knowledge of PC’s and networking environments
  • Experience with Excel, Visio, Power Point
  • Exposure to ISO 9000 and cGMP 21 CFR part 82
  • Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)