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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. 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 BDIS 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.
Typcially 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 • Experience with epoxies,, visual inspection, optical alignment • Ability to demonstrate dexterity and hand-eye coordination is desired • Must be able to perform repetitive task for 8 to 12 hours • Must be able to use microscope for duration of the shift as needed • Work in a clean room environment following all cleanliness protocols • Strict attention to detail A.S. degree, or vocational instruction in electro-mechanical assembly Experience working in a medical device manufacturing organization 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)
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