2nd Shift - Heart Valve Sewer

Ultimate Staffing; Irvine (CA); On-site; USD 27,000 - 38,000; Full time

Job summary

Ultimate Staffing is seeking a 2nd Shift Heart Valve Sewer - Medical Device Assembly in Irvine, CA. This position involves precision sewing and assembly of medical-device components, using a microscope, with the 2:30pm-11:00pm schedule and a pay rate of $23.50 per hour.

This is a long-term temporary assignment (12-18 months). You will work in a cleanroom, follow SOPs, document manufacturing records, and maintain quality and safety standards.

Qualifications

• High school diploma or GED required.
• Strong fine-motor skills and meticulous attention to detail.
• Experience or ability to work under a microscope for extended periods.
• Ability to read and follow written procedures in English.
• Experience in a cleanroom environment preferred.
• Able to work in a team with limited supervision.

Responsibilities

• Perform precision sewing and assembly of medical-device components using needles, scissors, and forceps.
• Work under a microscope for extended periods maintaining accuracy.
• Follow written work instructions, procedures, and quality requirements.
• Inspect and verify completed work and perform checks with teammates.
• Document required information in device history records.
• Maintain cleanroom, GMP, safety and environmental standards.
• Keep work area organized and perform general housekeeping.
• Complete training and perform tasks per established procedures.

Skills

Fine motor skills

Hand-eye coordination

Microscope work

Read and follow procedures

Team work

Cleanroom experience

Education

High school diploma or GED

Tools

Needles

Scissors

Forceps

Microscope

Job description

2nd Shift Heart Valve Sewer - Medical Device Assembly

Location:

Irvine, CA

Schedule:

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

Pay:

$23.50/hr

Type:

Long Term Temporary (12-18 months)

Position Summary

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 1:00 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.