Job Description

Job Description

Job Description

Assembler - Medical Devices

Location: Milpitas, CA
Pay Rate: $28.00/hour maximum, determined at time of offer
Schedule: Monday–Friday, 6:00 AM–2:30 PM
Work Arrangement: On-site
Interview Process: On-site interview

Position Overview

The Assembler - Medical Devices performs electro-mechanical assembly of flow cytometers, sub-assemblies, and related medical device products. This position assembles optical, mechanical, fluidic, and electronic components while following established procedures and maintaining high standards for quality, accuracy, and workmanship. The role works closely with assemblers, technicians, Quality Assurance personnel, engineers, and other production team members.

Key Responsibilities

• Perform instrument assembly according to released procedures.
• Assemble electro-mechanical, optical, mechanical, fluidic, and electronic components.
• Perform in-process inspections to ensure products meet specifications and quality standards.
• Complete documentation required for Device History Records (DHR).
• Read and follow assembly instructions, work orders, Bills of Materials (BOMs), SOPs, and other controlled documentation.
• Confirm work orders and accurately document required production data.
• Collaborate with engineers, technicians, and production personnel regarding assembly procedures.
• Support new product introductions and assist with developing and documenting assembly methods.
• Provide feedback on production methods, product design issues, quality, and operational efficiency.
• Assist with process and product documentation updates.
• Collect and document measurements and production data.
• Maintain a clean, organized, and safe work area.
• Complete timesheets, paperwork, and required training documentation accurately and on time.
• Support continuous improvement, quality improvement, cycle-time reduction, reliability, and operational efficiency initiatives.
• Perform other duties as assigned.

Qualifications

• High School Diploma or equivalent required.
• 2+ years of related experience in a high-tech manufacturing environment preferred.
• Experience in medical device manufacturing preferred.
• Experience with electro-mechanical assembly, hand tools, and production work.
• Experience working with optical, fluidic, electronic, or mechanical systems is preferred.
• Good mechanical aptitude, dexterity, and hand-eye coordination.
• Ability to reach, bend, and lift up to 35 lbs. daily.
• Ability to read and understand assembly instructions, work orders, BOMs, and SOPs.
• General computer skills and data-entry experience.
• Familiarity with Microsoft Word, Excel, Windows, and/or Mac OS.
• Ability to communicate effectively both verbally and in writing.
• Ability to work effectively in a team-oriented manufacturing environment.
• Knowledge of safety procedures and programs.
• Exposure to ISO 9000 and cGMP 21 CFR Part 820 preferred.

Preferred Experience

• Medical device manufacturing
• Laser-based optical systems
• Fluidic systems
• Digital and analog circuitry
• Excel, Visio, and PowerPoint
• LEAN Manufacturing
• Six Sigma concepts
• Demand Flow Technology (DFT)

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