Senior Technician, THV Sewing

Irvine, CA – Corporate Office / Controlled Cleanroom Environment

Job Description Summary

Manufacturing - Hourly / Assembly / Inspection. Manufacturing technician responsible for performing detailed sewing and tissue preparation processes used in the assembly of transcatheter heart valve devices. This role requires high manual dexterity, attention to detail, and adherence to strict regulatory, quality, and contamination control procedures within a controlled cleanroom manufacturing environment.

Job Responsibilities

• Use tools – needles, scissors, forceps, specialized tooling, microscope – to perform assigned steps, in rotation, in the sewing assembly of valves.
• 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 correspond to other work procedures, as requested, to provide support to operations processes.
• Assist Engineering in root cause analysis investigation for component nonconformance.
• Maintain compliance with company Quality Management System requirements, including applicable Good Manufacturing Practices (GMP) and regulatory standards.
• 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.
• Complete training as outlined in Training Plans and ability to train and certify others.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others.
• Other incidental duties: General work area housekeeping.

Qualifications

Required Education and Experience:

• The level of this role (Senior Technician I, II, or III) will be determined based on the candidate's experience, technical skills, and demonstrated competencies relevant to the position.
• Specific expectations for each level are further defined in the Technical & Operational Competency Matrix.
• 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.
• Previous biological tissue processing, GMP, clean room, medical device experience required.

Skills and Abilities Required for This Job

• Senior Technicians demonstrate advanced technical proficiency and play a key role in maintaining production quality, supporting team development, and ensuring consistent process execution.
• Ability to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.
• Ability to follow strict safety, contamination control, and cleanroom protocols.
• Must have ability to perform detailed tasks accurately.
• 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.
• Successful completion of required training and demonstrated competency on assigned manufacturing processes.
• 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.

Physical Requirements

• 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.
• Ability to perform highly detailed sewing operations while seated for extended periods during the work shift.
• Ability to maintain sustained concentration while performing intricate work under a microscope or magnification.
• Ability to use hands and fingers for fine manipulation of small components.
• Ability to perform work requiring close visual acuity.
• Ability to lift, carry, push, or pull materials and equipment weighing up to approximately 25 pounds.
• Ability to visually inspect small components with or without corrective lenses.
• Ability to work in a temperature-controlled environment with limited mobility while gowned.
• 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.