Instrument Assembler - Exp in Medical Device Industry

Position Instrument Assembler - Exp in Medical Device Industry Location Milpitas, CA Duration 12 Months Total Hours/week 40.00 Shift 1st Shift, Hours: 6:00 am to 2:30 pm. Client Medical Devices Company Job Category Industrial Employment Type Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Job 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; efficiently works on routine assignments. Understands implications of work and makes recommendations for improvement; generally receives some instruction and uses independent judgment for some activities. Might be asked to lead or supervise activities of other non‑exempt personnel; must work in a team‑oriented atmosphere with assemblers, technicians, QA personnel, and engineers; communicates effectively orally and in writing. Duties and Responsibilities Performs instrument assembly 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 read and understand assembly instructions, work orders, B‑of‑M, SOPs, and other documentation used to control 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. Provides feedback on production and methods, product design issues, continuously strives to improve product quality and operational efficiency. Provides support to project teams with objectives such as quality improvement, cost reduction, cycle‑time reduction, reliability improvement, operational efficiency, or new product introduction. Assists in creating and updating process and product documentation. Creates and maintains 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 regularly and strives to improve performance. Keeps work area clean, organized and safe. Fills out timesheets and all required paperwork accurately and on time; keeps training file up‑to‑date at all times. Other duties may be assigned. Minimum Qualifications – Knowledge and Skills Effectively communicates information and responds to questions verbally and in writing. Good mechanical aptitude, dexterity, and hand/eye coordination; can reach, bend, and lift 35 lbs daily. PC or MAC user; familiar with Word, Excel, Windows and/or MAC OS. Willing to be trained in other production areas where skill level requirements may be lower. Knowledge and adherence to safety procedures and programs. Exposure to ISO 9000 and cGMP 21 CFR part 820. Education and Experience 2+ years related experience in a high‑tech, manufacturing environment. High School diploma or equivalent, 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 PCs and networking environments; strong experience with Excel, Visio, PowerPoint. Strong knowledge of ISO 9000 and cGMP 21 CFR part 820; knowledge of LEAN Manufacturing, Six Sigma tools/concepts, Demand Flow Technology (DFT). #J-18808-Ljbffr MillenniumSoft Inc