Temp Associate Technician, THV Tissue Processing; 2nd Shift

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

• 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.

• 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 Jena Valve 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.

• 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.

• Strong attention to detail and ability to perform hands-on work accurately.
• Ability to follow detailed procedures and perform tasks consistently.
• Basic computer skills.
• Ability to handle animal tissue and perform wet processing procedures.
• Ability to read, comprehend and speak English, and good communication skills required.
• Ability to work effectively and collaborate within cross-functional teams.
• Ability to complete required training and demonstrate competency on assigned processes.
• Knowledge of or ability to learn GMP procedures and work effectively in a controlled manufacturing environment.

• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Must be able to stand, walk, and sit for prolonged periods of time.
• Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.
• Must be able to perform repetitive motions such as reaching and grasping.
• Ability to lift or move materials weighing up to 25 pounds.
• Ability to stand for extended periods during the work shift.
• Ability to perform tasks requiring close visual acuity and attention to detail.
• Ability to use hands and fingers to manipulate small tools and components.
• Ability to follow strict safety, contamination control, and cleanroom protocols.