Technician,THV Tissue Processing Job Irvine area,California USA,Manufacturing / Production

Job Title:
Technician, THV Tissue Processing

Supervisor/Manager Title: Supervisor, Tissue Processing

Job Description Summary: Applies skill and knowledge in the Solution Mixing, Cleaning/Autoclaving, and Tissue processing used to produce THV. Support for manufacturing & R&D tasks associated with new product development and commercialization of transcatheter heart valves.

Job Responsibilities:

Execute receiving, trimming, fixation, die-cutting and measurements for Porcine Pericardium tissue per JVT released procedures.
Technical training and knowledge of tissue harvesting for suppliers.
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.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
Be aware of Health and Safety information for the applicable processes utilized in the organization.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.

Required Education and Experience:

H.S. Diploma or equivalent.
Previous tissue processing, GMP, clean room, medical device experience preferred.
Minimum of 1 year experience on the job technical training in medical device industry.
Knowledge of procedures, equipment and tools used in the medical device industry or other regulated industries is required.

Skills and Abilities Required for This Job:

Must take initiative and be able to complete hands-on work.
Must handle single tasks with high attention to detail.
Basic computer skills required.
Must be able to handle animal tissue and wet processes.
Ability to read, comprehend and speak English, and good communication skills required.
Must be able to work effectively and collaborate within cross-functional teams.
Must be able to complete the applicable training requirements.
Must understand GMP procedures and be able to work in a controlled environment.


Increase/decrease your Search Radius (miles)



Job Posting Language