Technician, THV Tissue Processing (2nd Shift)

**Job Title:** Technician, THV Tissue Processing - **Technician I, THV Tissue Processing** - **Technician II, THV Tissue Processing** - **Technician III, 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. **Required Education and Experience:** - 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. *Technician I:* - 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 – BBR, leaflet cut, laser machine operation, with minimal trainer or lead verification. *Technician II:* - Executes more complex production tasks with increased efficiency and accuracy while ensuring adherence to SOPs,…