Associate Sewer

This role requires strong hand-eye coordination, fine motor skills, patience, and the ability to perform highly detailed work while using a microscope for extended periods. • Previous experience with sewing, precision assembly, microscope-based work, cleanroom manufacturing, GMP environments, medical-device manufacturing, laboratory work, or similar detailed production work is preferred.

Position: Associate Sewer
Location: Irvine, CA
Duration: 12+ Months Contract
Shift: Second Shift: 2:45 PM - 11:15 PM

Special Client Notes:
The initial interview may be conducted via Microsoft Teams. Candidates should expect an onsite job preview/skills assessment involving microscope use and precision sewing or dexterity-related tasks
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.

Key Responsibilities:
• Use tools – needles, scissors, forceps, specialized tooling, microscope – to perform assigned steps, in rotation, in the sewing assembly of valves
• 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 adherence with SOPs, including recording traceable information on device history records

Job Description:
The Associate Sewer performs detailed, precision sewing and assembly work on tissue and non-tissue components used in the production of medical devices. This role requires strong hand-eye coordination, fine motor skills, patience, and the ability to perform highly detailed work while using a microscope for extended periods. Work is performed in a cleanroom manufacturing environment and requires adherence to established procedures, quality standards, safety requirements, and documentation practices.

Key Responsibilities
• Perform precision sewing and assembly of medical-device components, including biological/tissue materials, using needles, scissors, forceps, microscopes, and other specialized tools.
• Perform detailed work under a microscope for extended periods while maintaining accuracy and consistency.
• Follow written work instructions, procedures, specifications, and quality requirements.
• Perform required inspections and verifications of completed work and successive checks on work completed by team members.
• Accurately document required information within device history records and other production documentation.
• Maintain established cleanroom, GMP, safety, and environmental requirements.
• Maintain an organized work area and perform general housekeeping duties as required.
• Complete required training and demonstrate the ability to consistently perform work according to established manufacturing procedures.

Required Skills / Qualifications
• Strong fine-motor skills and hand-eye coordination.
• Ability to perform precise, repetitive work requiring patience and sustained attention to detail.
• Ability and willingness to work extensively with a microscope.
• Ability to read, understand, and follow written procedures and manufacturing instructions in English.
• Ability to work effectively in a cleanroom environment and comply with applicable cleanroom restrictions and gowning requirements.
• Ability to work effectively in a team environment with limited supervision.
• High school diploma or GED required.

Preferred Qualifications
• 0–2 years of related manufacturing or production experience preferred.
• Previous experience with sewing, precision assembly, microscope-based work, cleanroom manufacturing, GMP environments, medical-device manufacturing, laboratory work, or similar detailed production work is preferred.

Sewing Experience Clarification
Prior sewing experience is preferred but is not required. Candidates with strong microscope experience, fine-motor dexterity, and the ability to learn precision medical-device sewing may be considered. Training on the specific sewing processes used in the role will be provided. This work differs from traditional machine or clothing sewing and involves precision work on medical-device and tissue components.

Schedule / Work Environment
• Second Shift: 2:45 PM - 11:15 PM
• All seven openings are on the same shift.

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.