Senior Technician, THV Sewing

Job Title:

Senior Technician, THV Sewing Senior Technician I, THV Sewing Senior Technician II, THV Sewing Senior Technician III, THV Sewing Role Level: Individual Contributor Supervisor/Manager

Title:

Associate Manager, THV Production and Technical Training

Job Location & Environment:
Irvine, CA – Corporate Office / Controlled Cleanroom Environment

Job Description

Summary:

Manufacturing - Hourly / Assembly / Inspection.

Manufacturing technician responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. This role requires high manual dexterity, attention to detail, and adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment

Job 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 execute work in assembly line.

Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.

Support activities 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 applicable Good Manufacturing Practices (GMP) and regulatory standards.

Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.

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.

Required

Education and Experience:

The level of this role (Senior Technician I, II, or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies relevant to the position.

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 designed to evaluate comprehension, language, and related abilities at a high school level.

Previous biological tissue processing, GMP, clean room, medical device experience required.

Senior Technician I:

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.

Communicate effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.

Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own and is able to provide feedback to team members.

Trusted technical resource; supports peers informally.

Sews all parts of the valve and is able to identify errors and correct them with minimal lead verification.

Able to perform additional sewing activities like Kitting, Serial Tag Attachment and overall reworking.

Senior Technician II:

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 is able to recommend corrections and communicate accordingly.

Perform…