Assembler

Stefanini Group•Irvine, CA

1d•Onsite

About The Position

Stefanini Group is hiring an Assembler in Irvine, California. This onsite role assembles and packs medical devices in cleanroom and non-cleanroom environments, following written and verbal specifications. The position works Monday through Friday for 40 hours per week on second shift, and requires availability to work all scheduled hours, including overtime. The Assembler follows manufacturing procedures and quality requirements while rotating through assigned operations and training modules. The role includes inspecting products and packaging, documenting manufacturing information accurately, maintaining equipment and supplies, and using required personal protective equipment. It also requires careful handling of materials and tools, strong manual dexterity, and communication with leads and supervisors.

Requirements

High school diploma, GED, or equivalent.
Ability to pass a visual acuity test with 20/20 corrected vision.
Ability to 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 intricate assembly and precision handling tasks with strong manual dexterity and attention to detail.
Ability to perform the essential functions onsite and use required PPE.
Availability to work Monday through Friday, 40 hours per week, on second shift, including scheduled overtime.

Responsibilities

Assemble medical devices according to specifications, procedures, and strict GMP requirements.
Pack medical devices in cleanroom or non-cleanroom environments.
Rotate through different manufacturing operations within the assigned process or training module.
Collaborate effectively with team members to foster strong relationships and minimize conflicts.
Document manufacturing process data, actions, or results accurately and according to good documentation practices (GDPs).
Assess product quality at each stage of development and promptly communicate product or process issues and deviations.
Perform in-process quality checks, including visual inspections of devices and packaging materials and air-flow testing of devices.
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.
Handle products, materials, and tools carefully to avoid damage or scrap.
Follow safety requirements, instructions, and procedures.
Use required personal protective equipment, including appropriate gowns, eyewear, face protection, shoe coverings, and gloves.
Work onsite and work all scheduled hours, including overtime.