Job Title: Temp Associate Technician, THV Tissue Processing

 

Role Level: Individual Contributor

 

Supervisor/Manager Title: Supervisor, Tissue Processing

 

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

 

Job Description Summary:

• Manufacturing - Hourly / Assembly / Inspection


• Manufacturing entry-level technician responsible for performing tissue preparation and processing activities used in the production of transcatheter heart valve devices. This role requires attention to detail, adherence to regulatory and quality system requirements, and the ability to work within a controlled cleanroom manufacturing environment.

 

Job Responsibilities:

• Execute receiving, trimming, fixation, die-cutting and measurements for Porcine Pericardium tissue per JVT released procedures.


• Use of tools – blades, scissors, forceps, dies, microscope – to perform tissue processing.


• Use of equipment – Fume hood, thickness measurement, press – to perform tissue processing.


• Perform verifications against specifications and defined failure modes.


• Complete all operations in accordance with work instructions, good manufacturing practices, good documenting practices in compliance with the JenaValve quality system, including recording traceable information in DHRs.


• Support all manufacturing-related aspects of the project within a team.


• Complete training as outlined in Training Plans.


• Support activities corresponding to other work procedures, as requested, to provide support to operations processes.


• Assist Engineering in root cause analysis investigation for component nonconformance.


• Assist in the process development and validation for new product introductions and continuous improvement projects.


• 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.


• Maintain a clean and organized work area in accordance with cleanroom and safety standards.


• Adhere to all Environmental Health and Safety (EHS) policies and procedures to prevent injury, protect others, and maintain a safe work environment.


• Support other operational activities and departmental needs as required.