Technician, THV Tissue Processing (2nd Shift)

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Job Title: Technician, THV Tissue Processing

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Supervisor, Tissue Processing

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

Job Description Summary:

Manufacturing - Hourly / Assembly / Inspection.
Manufacturing technician responsible for processing porcine pericardium tissue required to manufacture heart valve devices. Support for manufacturing and R&D tasks associated with new product development and commercialization of transcatheter heart valves.
This 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:

Execute receiving, chemical treatment, screening, cutting, measurements and inspection for Porcine Pericardium tissue per JVT released procedures.
Use of tools – blades, scissors, forceps, dies, magnifying lamp – to perform tissue processing.
Use of equipment – fume hood, thickness gauges, press machines, Litematics – to perform tissue processing.
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.
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.