Technician, THV Tissue Processing; 2nd Shift

Job Title

Technician, THV Tissue Processing

Individual Contributor

Senior Supervisor, Tissue Processing

Irvine, CA – Corporate Office / Controlled Cleanroom Environment

• 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

• 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.

• The level of this role (Technician I, II, 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 preferred.

• Performs standard production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Maintains required productivity and quality standards while completing documentation and process steps with minimal errors.
• 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.
• Is able to perform at least 4 of the core processes in addition to minimum one of the complex processes such as – B , leaflet cut, laser machine operation, with minimal trainer or lead verification.

• Executes more complex production tasks with increased efficiency and accuracy while ensuring adherence to SOPs, quality standards, and safety practices.
• Identifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.
• Actively supports team performance through effective communication, consistent productivity, and reliable documentation of manufacturing activities.
• Perform verifications, according to specifications, of completed steps, as well as…