Instrument Assembly Associate II
: Job Details :

Position: Instrument Assembly Associate IILocation : San Jose, CADuration : 12 Months ContractStart Time : 2:30 PMEnd Time : 11:00 PMTotal Hours/week :40.00Description: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 writingJustification:To support the production of options for Influx, Aria, Fusion, and Melody.Responsibilities:Performs instrument assembly by following released proceduresPerforms 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 efficiencyWill 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 safeFill 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 diploma2+ years related experience in a high tech, manufacturing environmentAbility 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 programsDesirable Qualifications:A.S. degree, or vocational instruction in electro-mechanical assemblyExperience working in a medical device manufacturing organizationExperience working in a clean room environment.Experience building: laser based optical systems, fluidic systems, digital and analog circuitryExtensive knowledge of PC's and networking environmentsExperience with Excel, Visio, Power PointExposure to ISO 9000 and cGMP 21 CFR part 82Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)