Precision Medical Device Sewer – Cleanroom Production (Irvine)

Hydrogen Group; Irvine (CA); On-site; USD 28,000 - 30,000; Full time

Job summary

Hydrogen Group, on behalf of our Irvine, CA client, seeks an Associate Sewer to join a global medical device manufacturer. The role involves sewing tissue and non‑tissue components under a microscope in a cleanroom, following regulatory and company guidelines.

You will use needles, scissors, forceps and a microscope to assemble device components, verify steps against specifications, and record traceable information in device history records.

Qualifications

• High school diploma or GED required.
• 0-2 years manufacturing/sewing experience required.
• Previous sewing, GMP, cleanroom or medical device manufacturing experience preferred.

Responsibilities

• Use tools including needles, scissors, forceps, specialised tooling and a microscope to perform assigned steps, in rotation, in the sewing assembly of device components.
• Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues.
• Review, follow and perform job functions in compliance with established work instructions and in adherence with SOPs, including recording traceable information on device history records.
• Complete ongoing job training on assembly process steps.
• Other incidental duties: general work area housekeeping.

Skills

Hand-eye coordination

Manual dexterity

Basic computer skills

English literacy

Education

High school diploma or GED

Tools

Microscope

Sewing tools

Job description

Hydrogen Group, on behalf of our Irvine, CA client, seeks an Associate Sewer to join a global medical device manufacturer. The role involves sewing tissue and non‑tissue components under a microscope in a cleanroom, following regulatory and company guidelines.

You will use needles, scissors, forceps and a microscope to assemble device components, verify steps against specifications, and record traceable information in device history records.