Instrument Assembly Specialist

8 hours ago

San Jose, California, United States MILLENNIUMSOFT Full time

Job Summary:

We are seeking a skilled Instrument Assembly Associate II to join our team at MillenniumSoft. As an Instrument Assembly Associate II, you will be responsible for performing electro-mechanical assembly of flow cytometers, sub-assemblies, and related medical device products.

Key Responsibilities:

  • Perform instrument assembly by following released procedures
  • Perform in-process inspection to ensure products meet specifications and standards
  • Generate 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 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
  • Fills 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

Requirements:

  • 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 PCs 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)

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