Senior Technician, THV Sewing

Job Title

Senior Technician, THV Sewing

• Location:
  
  Irvine, CA 92618
• Position Type:
  Full Time
• Education Level: High School
• Salary: $30.40 - $30.40 Hourly

Manufacturing – Hourly / Assembly / Inspection. The manufacturing technician is responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. Requires high manual dexterity, attention to detail, adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment.

• Use tools (needles, scissors, forceps, specialized tooling, microscope) to perform assigned steps of sewing and valve assembly.
• Perform verifications against specifications of completed steps and execute work on the assembly line.
• Review, follow, and perform job functions in compliance with established work instructions and SOPs, including recording traceable information on device history records.
• Support activities that correspond to other work procedures, as requested, to provide support to operations processes.
• Assist Engineering in root cause analysis investigation for component nonconformance.
• Maintain compliance with company Quality Management System requirements, including GMP and regulatory standards.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and ability to work full scheduled shifts and overtime as required.
• Complete training as outlined in Training Plans and ability to train and certify others.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.
• Other incidental duties: general work area housekeeping.

The level (Senior Technician I, II or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies. Specific expectations for each level are further defined in the Technical & Operational Competency Matrix.

High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment.

Previous biological tissue processing, GMP, cleanroom, medical device experience required.

• Highly skilled at performing production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Maintains consistent productivity and quality standards while completing documentation and process steps with minimal errors.
• Identifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.
• Communicates effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.
• Performs verifications, according to specifications, of completed steps, and successive reviews of steps performed by team members, providing feedback.
• Trusted technical resource; supports peers informally.
• Sews all parts of the valve and identifies errors, correcting them with minimal lead verification.
• Able to perform additional sewing activities like kitting, serial tag attachment, and overall reworking.

• Shows expertise at performing production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Identifies process issues or deviations and recommends corrections, communicating accordingly.
• Performs verifications, according to specifications, of completed steps, and successive reviews of steps performed by team members, providing feedback.
• Trusted technical resource; prevents recurring issues and influences peers and provides guidance.
• Sews all parts of the valve and identifies errors, correcting them with minimal to no lead verification.
• Able to perform additional sewing activities like kitting, serial tag attachment, and overall reworking.
• Exceptional reliability and professionalism; consistently meets or exceeds attendance and…