Assembly 2- General.
San Jose
hace 2 horas

Description :

JOB SUMMARYPerforms 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 some instruction on daily work, uses independent judgment for some activities and employs a moderate degree of initiative.

May be asked to lead or supervise the activities of other non-exempt personnel. 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 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.
  • May support new product introductions; determines, develops and documents optimal assembly methods.
  • 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
  • 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. MINIMUM QUALIFICATIONSKNOWLEDGE AND SKILLSAbility 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 basisPC or MAC user, familiar with : Word, Excel, Windows and / or MAC OSMust be willing to be trained in other areas of production where the skill level requirements may be lowerKnowledge and adherence to safety procedures and programsExposure to ISO 9000 and cGMP 21 CFR part 820 EDUCATION AND EXPERIENCE3+ years related experience in a high tech, manufacturing environmentHigh School diploma or equivalentA.

    S. degree, or vocational instruction in electro-mechanical assemblyExperience working in a medical device manufacturing organizationExperience building : laser based optical systems, fluidic systems, digital and analog circuitryExtensive knowledge of PC’s and networking environmentsStrong experience with Excel, Visio, Power PointStrong knowledge of ISO 9000 and cGMP 21 CFR part 820Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)Requisition Number of Positions BD04123JD

    Skills Required :

    Previous experience, medical device assembly, proof of Education

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