Sewing Assembly Tech – Medical Devices (Cleanroom)

Aleron; Irvine (CA); On-site; USD 30,307 - 41,328; Full time

Job summary

Aleron is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role focuses on manufacturing medical devices with strict GMP and regulatory requirements in a controlled cleanroom environment.

The position demands high manual dexterity, attention to detail, and teamwork. You will perform sewing assembly steps, verify work against specifications, maintain proper documentation, and support engineering investigations as needed.

Qualifications

• High school diploma or GED required.
• Minimum 1 year experience in medical assembly.
• Ability to work in a cleanroom and handle animal tissue.
• Must be able to read, comprehend, and speak English.
• Must adhere to GMP and quality standards.

Responsibilities

• Perform sewing assembly steps for transcatheter heart valve devices.
• Verify completed steps against specifications.
• Follow work instructions and record traceable data.
• Support engineering root cause analysis when nonconformance occurs.
• Maintain GMP compliance and tidy, organized work areas.
• General housekeeping and collaboration with cross functional teams.

Skills

Manual dexterity

Attention to detail

Cleanroom

Team collaboration

English communication

Basic computer skills

Education

High School Diploma or GED

Tools

Needles

Scissors

Forceps

Specialized tooling

Microscope

Job description

Aleron is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role focuses on manufacturing medical devices with strict GMP and regulatory requirements in a controlled cleanroom environment.

The position demands high manual dexterity, attention to detail, and teamwork. You will perform sewing assembly steps, verify work against specifications, maintain proper documentation, and support engineering investigations as needed.