Technician, THV Tissue Processing presso JENAVALVE TECHNOLOGY INC

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.