Instrument Assembler - Exp in Medical Device Industry

Position

Instrument Assembler - Exp in Medical Device Industry

Milpitas, CA

12 Months

40.00

1st Shift,

Hours:

6:00 am to 2:30 pm.

Medical Devices Company

Industrial

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

• 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.

• 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.

• 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.

• 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).