Associate Sewer, Medical Device Manufacturing

Hydrogen Group; Irvine (CA); On-site; USD 25,000 - 36,000; Full time

Job summary

Hydrogen Group in Irvine, CA is hiring Associate Sewers to join its production team. The role involves precision sewing and assembly of tissue and non-tissue components for medical devices, performed under a microscope in a cleanroom environment. Prior sewing experience is a plus, but full training is provided.

Two shifts are available: First 4:30 AM–1:00 PM or Second 2:45 PM–11:15 PM. This is a 6-month W2 contract with pay up to $22/hr. adherence to GMP, safety, and documentation is required.

Qualifications

• High school diploma or GED required.
• 0 to 2 years of related manufacturing or production experience preferred.
• Experience with sewing, precision assembly, microscope-based work, cleanroom manufacturing, GMP environments, medical device manufacturing, laboratory work or similar detailed production work preferred.
• Candidates without sewing experience but with strong microscope experience and fine-motor dexterity will be considered; this is precision work on medical device and tissue components, not machine or clothing sewing.

Responsibilities

• Sew and assemble medical device components, including biological tissue materials, using needles, scissors, forceps, microscopes, and specialized tooling
• Rotate through assigned steps in the sewing assembly of valves
• Carry out detailed microscope work for extended periods while keeping accuracy and consistency high
• Follow written work instructions, SOPs, specifications, and quality requirements
• Inspect and verify completed work against specifications, and complete successive checks on work done by team members
• Record accurate, traceable information in device history records and other production documentation
• Maintain cleanroom, GMP, safety, and environmental standards at all times
• Keep the work area organized and complete general housekeeping duties as needed
• Complete all required training and consistently perform work in line with established manufacturing procedures

Skills

Fine motor skills

Hand-eye coordination

Attention to detail

Team player

Microscope work

Education

High school diploma or GED

Tools

Microscope

Job description

Location: Irvine, CA (Onsite)

Schedule: Monday to Friday, choice of two shifts:

• First Shift: 4:30 AM to 1:00 PM
• Second Shift: 2:45 PM to 11:15 PM

Duration: 6-Month W2 Contract

Pay Rate: Up to $22/hr

Position Summary

Our client, a global medical device manufacturer, is hiring Associate Sewers to join its production team in Irvine. In this role, you will perform detailed, precision sewing and assembly of tissue and non-tissue components used to build medical devices, working under a microscope in a cleanroom environment. The work requires steady hands, strong hand-eye coordination, patience, and close attention to detail, as well as careful adherence to procedures, quality standards, safety requirements, and documentation practices. Prior sewing experience is a plus but not essential, as full training on the specific sewing processes is provided.

Essential Functions and Responsibilities

• Sew and assemble medical device components, including biological tissue materials, using needles, scissors, forceps, microscopes, and specialized tooling
• Rotate through assigned steps in the sewing assembly of valves
• Carry out detailed microscope work for extended periods while keeping accuracy and consistency high
• Follow written work instructions, SOPs, specifications, and quality requirements
• Inspect and verify completed work against specifications, and complete successive checks on work done by team members
• Record accurate, traceable information in device history records and other production documentation
• Maintain cleanroom, GMP, safety, and environmental standards at all times
• Keep the work area organized and complete general housekeeping duties as needed
• Complete all required training and consistently perform work in line with established manufacturing procedures

Education/Experience

• High school diploma or GED required
• 0 to 2 years of related manufacturing or production experience preferred
• Experience with sewing, precision assembly, microscope-based work, cleanroom manufacturing, GMP environments, medical device manufacturing, laboratory work or similar detailed production work preferred
• Candidates without sewing experience but with strong microscope experience and fine-motor dexterity will be considered; this is precision work on medical device and tissue components, not machine or clothing sewing

Knowledge/Skills

• Strong fine-motor skills and hand-eye coordination
• Able to perform precise, repetitive work that requires patience and sustained focus
• Comfortable working extensively with a microscope
• Able to read, understand, and follow written procedures and manufacturing instructions in English
• Able to work in a cleanroom and follow gowning and cleanroom restrictions
• Works well in a team with limited supervision

...