Technician I, Delivery System

Technician I, Delivery System

Irvine, CA – Corporate Office/ Controlled Clean Room Environment and Pack Out Areas

Manufacturing - Hourly / Assembly. Responsible for manufacturing activities related to the assembly of delivery systems used with transcatheter heart valve devices. Work is performed in a cleanroom manufacturing environment and requires attention to detail, manual dexterity, and following company procedures.

• Perform manual assembly of delivery system components and related products following approved work instructions and manufacturing procedures within a cleanroom environment.
• Complete all assembly operations in accordance with work instructions, quality requirements, and good documentation practices (GDP/GMP).
• Maintain attention to detail while performing precision assembly tasks using tools such as microscopes, tweezers, cutters, and other production equipment.
• Complete production documentation accurately and in compliance with company quality system requirements.
• Identify basic quality or process issues during assembly activities and escalate concerns to supervisors or quality personnel as appropriate.
• Maintain clean and organized workstations in accordance with cleanroom standards and company procedures.
• Support team production goals by contributing across multiple manufacturing activities including assembly, packaging, inspection, and material handling as needed.
• Complete required training and maintain certification for assigned production processes.
• Adhere to company policies, quality system requirements, and safety procedures.
• Support inventory handling and movement of raw materials and work-in-process components as required for production operations.
• Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required.
• Follow all Environmental Health and Safety (EHS) procedures for the manufacturing and cleanroom environment.
• Perform other duties as assigned.

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 manufacturing, assembly, or regulated/cleanroom production environments preferred.

• Ability to work effectively in a regulated manufacturing environment.
• Ability to follow written procedures and work instructions.
• Strong attention to detail while performing assembly tasks.
• Ability to communicate effectively with team members and supervisors.
• Ability to read, comprehend and speak English, and good communication skills required.
• Basic computer skills.

• 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 stand, sit, or walk for prolonged periods while performing detailed assembly tasks.
• Ability to perform fine motor skills and repetitive hand motions required for manual assembly and inspection.
• Ability to lift, carry, push, or pull materials and equipment weighing up to approximately 50 pounds.
• Ability to visually inspect small components with or without corrective lenses.
• Ability to work in a temperature-controlled environment with limited mobility while wearing required gowning.
• 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.