Technician, THV Tissue Processing

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 10,000 - 60,000; Full time

Job summary

An established industry player is seeking a dedicated Technician for THV Tissue Processing. This role involves hands-on work in a controlled environment, executing essential tasks related to tissue processing for transcatheter heart valves. Candidates should possess a high school diploma and ideally have experience in the medical device industry, particularly in GMP settings. This position offers a unique opportunity to contribute to innovative projects while ensuring compliance with industry standards. If you are detail-oriented and thrive in a collaborative environment, this could be the perfect role for you.

Qualifications

• 1+ year experience in the medical device industry preferred.
• Knowledge of procedures and tools in regulated industries required.

Responsibilities

• Execute tissue processing tasks adhering to JVT procedures.
• Support manufacturing and R&D for new product development.
• Ensure compliance with GMP and quality system standards.

Skills

Attention to Detail

Initiative

Basic Computer Skills

Communication Skills

Collaboration

Understanding GMP Procedures

Education

High School Diploma or equivalent

Tools

Blades

Scissors

Forceps

Microscope

Fume Hood

Thickness Measurement Equipment

Press

Job description

Job Details

Job Location: Irvine, CA

Position Type: Full Time

Education Level: High School

Salary Range: $25.00 - $25.00 Hourly

Description

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 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.
• 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.

Qualifications

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.