Technician I, Delivery System

Job Title:

Technician, Delivery System

• Technician I, Delivery System
• Technician II, Delivery System
• Technician III, Delivery System

• 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 upscale 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.

• 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.

• Basic familiarity with hand tools, microscopes, and standard assembly processes.
• Works under guidance while developing technical proficiency.
• Ability to learn and perform assigned assembly tasks following work instructions and standard operating procedures.
• Ability to work under guidance while developing technical skills in catheter assembly and related manufacturing processes.
• Ability to follow GMP documentation practices with oversight.
• Ability to maintain attention to detail while performing routine assembly tasks.
• Ability to communicate effectively with peers and supervisors regarding work status or issues encountered.

• Demonstrated ability to perform precision assembly tasks in a regulated or cleanroom environment.
• Able to perform trained tasks independently with minimal supervision.
• Ability to perform trained catheter assembly and manufacturing tasks independently with minimal supervision.
• Ability to maintain consistent workmanship while meeting established production and quality standards.
• Ability to complete production documentation accurately and in compliance with GDP/GMP requirements.
• Ability to identify basic process or quality issues and elevate concerns appropriately.
• Ability to support team…