&2 Shift Assembly

Medical Device Production Technician

This role is responsible for producing high-quality medical devices in a cleanroom environment, with a strong focus on precision, safety, and compliance with Good Manufacturing Practices (GMPs). You will work extensively with polymers, spray coating formulations, microscopes, and specialized equipment to support the manufacture, inspection, and packaging of medical devices.

• Operate production machinery to manufacture medical devices according to established specifications and quality standards.
• Formulate polymers, excipient solutions, and spray coating formulations following defined procedures.
• Set up coating machines, perform coating operations, and ensure consistent application on balloon catheters.
• Inspect products using a microscope to verify quality, dimensions, and adherence to specifications.
• Fold balloon catheters and assemble components required for top-level work orders.
• Follow detailed manufacturing instructions and accurately update job documentation to ensure full traceability.
• Prepare products for sterilization and perform product packing for both sterile and non-sterile finished and semi-finished goods.
• Conduct basic testing of formulations and document results according to GMP requirements.
• Identify and communicate supply needs to ensure materials are replenished in a timely manner.
• Complete routine and periodic cleaning activities in the production and cleanroom areas as required.
• Work safely and effectively with chemicals, following all safety and handling procedures.
• Adhere to GMPs and cleanroom protocols, including proper gowning and de-gowning procedures.
• Support production demands by working overtime and on weekends as needed.

• High school diploma or equivalent education.
• At least 1 year of experience in the medical device industry, ideally in a manufacturing or production role.
• Familiarity with cleanroom environments, including gowning and de-gowning processes.
• Ability to stand for the entire shift and perform repetitive tasks with consistent accuracy.
• Willingness to work overtime and be open to weekend shifts to support production demands.
• Comfort working with chemicals and following safety procedures.
• Proficiency in English at a medium level, sufficient to read, understand, and follow written manufacturing instructions and documentation.
• Experience working under Good Manufacturing Practices (GMPs) or similar regulated environments.
• Basic experience with microscopes, or strong willingness to learn and use microscopes for product inspection.

• 1+ year of medical device manufacturing experience with microscope use is preferred.
• Experience in pharmaceutical, aseptic, or formulation environments is an advantage.
• Prior experience in assembly work within a cleanroom setting.
• Strong attention to detail and ability to maintain accurate production and traceability records.
• Comfort working with precision equipment and small components.
• Ability to follow standard operating procedures and work instructions consistently.

You will join a growing organization at an exciting time, with strong growth forecasted as the product moves toward FDA approval in the United States. The role offers the opportunity to work on innovative medical technologies that have a direct impact on patient care, while gaining valuable experience in a regulated, cleanroom-based environment. You will develop specialized skills in medical device manufacturing, formulation, and inspection, and contribute to a team that values quality, safety, and continuous improvement.

You will work primarily in a cleanroom environment that requires strict adherence to gowning and de-gowning procedures and cleanroom protocols. The role involves standing for the entire shift and performing hands-on tasks with medical devices, polymers, chemicals, and precision equipment, including microscopes and coating machines. You will follow GMP guidelines and aseptic practices while working with sterile and non-sterile products. The schedule includes two 30-minute breaks per shift: one unpaid meal break and one paid break, replacing shorter breaks.

Overtime and weekend work may be required to support high production demand. Cleanroom attire and personal protective equipment are mandatory and provided in accordance with facility standards.

This is a Contract to Hire position based out of Irvine, CA.

The pay range for this position is $22.00 - $24.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the…