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)