Technician I, Delivery System
Summary
Assembles precision medical-device components in a cleanroom, following strict quality and safety protocols to build delivery systems for transcatheter heart valves.
Job Title: Technician, Delivery System
- Technician I, Delivery System
- Technician II, Delivery System
- Technician III, Delivery System
Role Level: Individual Contributor
Supervisor/Manager Title: Supervisor, Delivery System
Job Location & Environment: Irvine, CA – Corporate Office/ Controlled Clean Room Environment and Pack Out Areas
Job Description Summary:
- 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.
Job Responsibilities:
- 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.