Technician I, Delivery System

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 27,552 - 44,083; Full time

Job summary

JenaValve Technology, Inc. in Irvine, CA is seeking a Technician, Delivery System to perform manual assembly of delivery system components in a controlled cleanroom environment, following GMP/GDP documentation and work instructions.

The Technician I–III levels require attention to detail, use of microscopes and hand tools, and adherence to safety and quality procedures, with opportunities across assembly, packaging, inspection, and material handling.

Qualifications

• High school diploma or equivalent required; may demonstrate equivalent competency.
• Experience in manufacturing, assembly, or regulated/cleanroom production environments preferred.
• Ability to follow GMP documentation practices and work instructions.

Responsibilities

• Perform manual assembly of delivery system components in a cleanroom environment.
• Complete production tasks per work instructions, GDP/GMP, and quality requirements.
• Maintain clean and organized workstations in line with cleanroom standards.
• Identify basic quality or process issues and escalate to supervisors or quality personnel as appropriate.
• Support multiple production activities including assembly, packaging, inspection, and material handling.
• Complete required training and maintain certifications for assigned production processes.

Skills

Hand tools

Microscopes

Assembly processes

Education

High school diploma or equivalent

Job description

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 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.

Qualifications

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.

Technician I

• 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.

Technician II

• 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 productivity by contributing across multiple production activities as needed.

Technician III

• Demonstrated proficiency performing complex or multi-step assembly operations.
• Consistently performs work independently with strong attention to quality, documentation accuracy, and process adherence.
• Demonstrated ability to execute complex or multi-step assembly tasks with high consistency and minimal errors.
• Ability to identify quality issues at the source and take appropriate action to prevent downstream defects.
• Strong understanding of manufacturing processes and work instructions across multiple assemblies.
• Ability to support training and provide guidance to less experienced technicians.
• Ability to maintain high standards of workmanship, documentation accuracy, and process adherence.

Skills And Abilities Required For This Job

• 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.

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 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.