Senior Technician, THV Sewing

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Job Title: Senior Technician, 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.