Assembler

Stefanini Group•Irvine, CA

1d•Onsite

About The Position

Stefanini Group is hiring an Assembler to assemble and pack medical devices in cleanroom and non-cleanroom environments, following written and verbal specifications. This onsite position is in Irvine, California, and works a Monday–Friday schedule of 40 hours on the second shift. The role requires working all scheduled hours, including overtime when required. The Assembler follows manufacturing procedures and good manufacturing and documentation practices, rotates among assigned manufacturing operations, performs in-process quality inspections, and promptly communicates product or process issues. The role also involves documenting manufacturing information, maintaining equipment and supplies, following safety procedures, and using required personal protective equipment and cleanroom gowning procedures. The work involves precise, repetitive hand and finger movements, close visual inspection and assembly of small parts, and occasional exertion of up to 10 pounds. The worker may encounter noise and workplace hazards such as moving mechanical parts, electrical current, chemicals, or high heat. Stefanini describes itself as a global provider of outsourcing, IT consulting, systems integration, application, and staffing services to enterprises across multiple markets.

Requirements

High school diploma, GED, or equivalent.
Pass a visual acuity test, with 20/20 corrected vision.
Pass Particulate Matter Certification.
Ability to read and comprehend manufacturing procedures.
Ability to read, write, and understand English.
Ability to communicate with leads and supervisors.
Ability to perform detailed visual inspection and precision assembly of small parts.
Ability to meet the physical demands of the position, including repetitive wrist, hand, and finger movements and sedentary work involving up to 10 pounds of force occasionally.
Ability to work onsite in Irvine, California.

Responsibilities

Assemble medical devices in accordance with GMPs, specifications, and procedures.
Pack medical devices according to written and verbal specifications.
Be available to rotate among different operations within the assigned manufacturing process or training module.
Work effectively with team members to build strong relationships and minimize conflicts.
When needed, document manufacturing process data or results accurately and according to GDPs.
Assess product quality at each stage of development and immediately communicate product or process issues and deviations.
Perform in-process quality inspections, including visual inspection of devices and packaging materials and air-flow testing of devices.
Document actions, data, and results related to manufacturing processes accurately and in accordance with good documentation practices.
Use sanitizer as part of the gowning process when entering the cleanroom.
Clean and organize manufacturing equipment, tools, and supplies.
Use manual dexterity and precision when assembling products and handling tools and materials; take care to avoid damage or scrap.
Follow safety requirements, instructions, and procedures.
Work onsite and use required personal protective equipment, including gowning, eye wear, face protection, shoe coverings, and gloves.
Work all scheduled hours, including overtime.