Heart Valve Sewing Technician

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 42,000 - 66,000; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA is seeking a Manufacturing Technician to support the THV sewing assembly in a controlled cleanroom environment.

The role involves precision sewing, tissue preparation, and adherence to GMP and regulatory standards. Candidates should have a high school diploma, manual dexterity, and the ability to work in a regulated manufacturing setting with attention to detail.

Qualifications

• High school diploma or equivalent required.
• Experience in regulated/ cleanroom production environments preferred.
• Performs standard production tasks with accuracy and follows SOPs.

Responsibilities

• Use needles, scissors, forceps, specialized tools, and microscope to perform sewing assembly steps.
• Perform verifications against specifications of completed steps in the assembly line.
• Follow work instructions and SOPs; record traceable information in device history records.
• Support other procedures to assist operations, and help with root cause analysis for component nonconformance.
• Maintain GMP compliance and adhere to contamination control regulations in a cleanroom environment.

Skills

High manual dexterity

Attention to detail

English communication

Cleanroom protocol knowledge

Education

High school diploma or equivalent

Tools

Needles

Scissors

Forceps

Microscope

Job description

JenaValve Technology, Inc. in Irvine, CA is seeking a Manufacturing Technician to support the THV sewing assembly in a controlled cleanroom environment.

The role involves precision sewing, tissue preparation, and adherence to GMP and regulatory standards. Candidates should have a high school diploma, manual dexterity, and the ability to work in a regulated manufacturing setting with attention to detail.