Associate Sewer (Irvine, CA)

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

Location: Irvine, CA (Onsite)

Schedule: 4:30am - 1:00pm PST, Monday to Friday

Duration: 12 Month Contract

Pay Rate: $20.95/hr

Position Summary

Our client is a global medical device manufacturer seeking an Associate Sewer to join its production team in Irvine, CA. The role applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines. Work is performed under a microscope in a cleanroom manufacturing environment.

Essential Functions and 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.

Education/Experience

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

Knowledge/Skills

• Good hand-eye coordination and manual dexterity, required.
• Basic computer skills, required.
• Due to the specific duties of this job, you must be able to read, comprehend, write and speak English.
• Knowledge of and adherence to the client's Environmental Health & Safety and Quality guidelines as they relate to cleanroom medical device manufacturing.
• Ability to work in a team environment and with minimum supervision by following detailed manufacturing instructions.
• Adherence to all company rules and requirements (e.g. Environmental Health & Safety rules), taking adequate control measures to prevent injury to self and others, and to protect the environment and prevent pollution within their span of influence or control.