Heart Valve Sewing Tech — Cleanroom Assembly

Acara Solutions, Inc.; Irvine (CA); On-site; USD 46,000 - 63,000; Full time

Job summary

Acara Solutions is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role involves precise sewing, tissue preparation, and strict adherence to GMP and cleanroom standards.

The candidate should have at least 2 years sewing heart valves and be comfortable working in a regulated manufacturing environment with detailed documentation and collaboration across teams.

Qualifications

• High School Diploma or GED required.
• Minimum 2 years sewing heart valves experience.
• Ability to work in a cleanroom environment.

Responsibilities

• Perform sewing and tissue preparation steps for valve assembly.
• Verify completed steps against specifications and document results.
• Follow SOPs and record traceable information in device history records.
• Support operations and assist Engineering in root cause analysis of nonconformance.
• Maintain GMP and regulatory compliance in a cleanroom setting.
• Attend full scheduled shifts and overtime as needed to meet production needs.
• General housekeeping and team collaboration.

Skills

Manual dexterity

Attention to detail

Cleanroom experience

English communication

Reading specifications

Education

High School Diploma or GED

Tools

Small hand tools

Job description

Acara Solutions is seeking an Associate Technician for sewing assembly in Irvine, CA. This contract-to-direct role involves precise sewing, tissue preparation, and strict adherence to GMP and cleanroom standards.

The candidate should have at least 2 years sewing heart valves and be comfortable working in a regulated manufacturing environment with detailed documentation and collaboration across teams.