Technician, THV Sewing

Job description
Description

Job Title : Technician, THV Sewing

Supervisor/Manager Title: Senior Supervisor, THV Production and Technical Training

Job Description Summary:
• Manufacturing - Hourly / Assembly / Inspection.
• Operation: Irvine, California.
• Applies skill and dexterity in the sewing of tissue and non-tissue components and the tissue processing used to produce medical devices, in keeping with regulatory and company guidelines.

Job Responsibilities:
• Use tools – needles, scissors, forceps, specialized tooling, microscope – to perform assigned steps, in rotation, in the sewing assembly of valves.
• Execute receiving, trimming, fixation, die cutting and measurements for Porcine Pericardium tissue per JVT released procedures.
• Use of equipment – Fume hood, Litematic, press – to perform tissue processing.
• Perform verifications, against specifications, of completed steps, and execute work in assembly line.
• Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• 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.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
• Other incidental duties: General work area housekeeping

Qualifications

Required Education and Experience:
• H.S. Diploma or equivalent.
• Previous sewing, clean room, medical device experience.

Skills and Abilities Required for This Job:
• Ability to use small hand tools, hand eye coordination, and high manual dexterity.
• Must be able to handle animal tissue and wet processes.
• Must be able to work effectively and collaborate within cross functional teams.
• Ability to read, comprehend and speak English, and good communication skills required.
• Knowledge of and adherence to Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Must be able to work in a team environment and with minimum supervision by following detailed manufacturing instructions.
• Successful completion of ongoing job training of assembly process steps.
• Adhere to all rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
• Basic computer skills.