Heart Valve Sewer - Medical Device Assembly
Location: Irvine, CA
Schedule & Pay:
1st Shift - Mon to Fri (4:30am-1:00pm) - $22/hour
2nd Shift - Mon to Fri (2:30pm-11:00pm) - $23.50/hour
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.
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.