Instrument Assembler

Position : Instrument Assembler

Location : San Jose, CA

Duration : 12 Months

Total Hours/week : 40

1st Shift

Client : Medical Devices Company

Job Category : Light Industrial

Level of Experience : Entry - Level

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

Hours 6 am to 2:30 pm

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.
• Performs instrument assembly by following released procedures.
• 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.
• Must have the ability to create and maintain productive working relationships within the work team and with other functions. Collaborates with peers to achieve shared departmental goals.
• 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.
• Other duties may be assigned.
• 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, and Windows.
• 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

• Occasionally, this position will also require assisting packaging base on business needs.
• Responsible for the manual inspection, labeling, and packaging of clinical and commercial products.
• Perform finished product packaging as required to satisfy all customer, internal, clinical, and other demand.
• Ensure finished product is packaged in accordance with procedures and Quality specifications.
• Inspect in-process packaging, components to ensure consistent quality and remove defective products and packaging material.
• Perform routine cleaning of packaging station and processing equipment.
• Abide by all personal protective equipment and product contamination control (i.e., gowning) requirements.
• Handle hazardous waste as appropriate.
• Work well in a team environment.
• Good documentation practices.
• Must be willing and able to work a flexible work schedule including static or rotating shifts and overtime as required.

Minimum Requirements (Must Haves):

• Requires a high school or GED degree.
• 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.
• Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS
• Knowledge of PC's and networking environments
• Must be able to follow established methods and procedures in performing ex: assembly of optical, mechanical, fluidic and/or electronic components, assemblies, and testing.

Desirable Qualifications (Nice to Have):

• Experience working in a medical device manufacturing organization.
• 3+ years related experience in a high tech, manufacturing environment.
• Experience with Excel, Visio, Power Point
• Knowledge of ISO 9000, cGMP 21 CFR part 820 or FDA
• Performs electro-mechanical assembly and sub-assemblies for medical device products.
• SAP experience preferred.