2nd Shift - Heart Valve Sewer

Ultimate Staffing Services; Irvine (CA); On-site; USD 26,000 - 37,000; Full time

Job summary

Ultimate Staffing Services in Irvine, CA is seeking a 2nd Shift Heart Valve Sewer for precision sewing and assembly of medical-device components. The role requires working under a microscope in a cleanroom, Monday to Friday, 2:30pm-11:00pm, with a pay rate of $23.50 per hour.

This is a long-term temporary position (12-18 months) in a regulated manufacturing environment. Candidates should have a high school diploma or GED, strong fine-motor skills, and the ability to read and follow English

Qualifications

• High school diploma or GED required.
• Strong fine-motor skills and hand-eye coordination.
• Ability to read, understand, and follow written procedures in English.
• Willingness to work in a cleanroom environment and gowning requirements.
• Able to work with a microscope for extended periods.

Responsibilities

• Perform precision sewing and assembly of medical-device components under a microscope.
• Document required information in device history records and perform peer verifications.
• Follow written work instructions, procedures, specifications, and quality requirements.
• Maintain cleanroom, GMP, safety, and environmental standards.
• Keep organized work area and complete training as required.
• Collaborate with team to ensure quality and throughput.

Skills

Fine motor skills

Attention to detail

Microscope work

Teamwork

Reading procedures in English

Education

High school diploma or GED

Tools

Microscope

Needle & forceps

Cleanroom equipment

Job description

2nd Shift - Heart Valve Sewer (JN -092026-432013) Irvine, California

Salary: USD0 - USD23.5 per hour

2nd Shift Heart Valve Sewer - Medical Device Assembly

Location: Irvine, CA

Schedule: 2 nd Shift - Mon to Fri (2:30pm-11:00pm)

Pay: $23.50/hr

Type: Long Term Temporary (12-18 months)

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.

• First shift: Monday through Friday, 4:30 a.m. to 1:0.0 p.m.
• All five openings are on the same shift.
• Candidates may start individually as they become available; the team does not need to wait until all five positions are filled.

Comments for Suppliers: 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-re

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