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Job Title: Technician, THV Sewing

• Technician I, THV Sewing
• Technician II, THV Sewing
• Technician III, THV Sewing

Role Level: Individual Contributor

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

Job Location & Environment: 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.
• Other incidental duties: General work area housekeeping.

Required Education and Experience:

• The level of this role (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.
• Experience in regulated/ cleanroom production environments preferred.

Technician I:

• Performs standard production tasks independently while following established work instructions, SOPs, and safety requirements with consistent accuracy and reliability.
• Maintains required productivity and quality standards while completing documentation and process steps with minimal errors.
• Communicate effectively with team members and supervisors while contributing to a collaborative work environment and maintaining reliable attendance and professional conduct.
• Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own
• Is able to perform a minimum of three sections of the heart valve manufacturing with minimal trainer or lead verification.

Technician II:

• Executes more complex production tasks with increased efficiency and accuracy while ensuring adherence to SOPs, quality standards, and safety practices.
• Identifies minor process issues or deviations and communicates them appropriately to leads or supervisors to support continuous improvement and operational reliability.
• Actively supports team performance through effective communication, consistent productivity, and reliable documentation of manufacturing activities.
• Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members on their own
• Is able perform more than three sections of the heart valve manufacturing with minimal trainer or lead verification.

Technician III:

• Demonstrates mastery of production operations and independently performs complex or specialized tasks while maintaining high standards of quality, safety, and productivity.
• Applies strong process knowledge to ensure accurate execution of procedures, assist with troubleshooting, and help prevent recurring errors.
• Serves as a trusted technical resource to peers by sharing best practices, supporting team coordination, and maintaining exemplary reliability and professionalism.
• Perform verifications, according to specifications, of completed steps, as well as successive reviews of steps performed by team members and ability to provide feedback to coworkers
• Is able to perform all of the steps of the heart valve manufacturing with minimal trainer or lead verification.

Skills and Abilities Required for This Job:

• Ability to use small hand tools, steady hand-eye coordination, and high manual dexterity/fine motor skills.
• 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 follow strict safety, contamination control, and cleanroom protocols.
• 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.
• Ability to lift or move materials up to 25 pounds.