Medical Device Assembler - 1st Shift

Assembler – 1st Shift

This role is responsible for assembling and producing high-quality medical devices in a primarily cleanroom environment. You will work with polymers and spray coating formulations, operate microscopes and specialized coating equipment, and ensure all products meet strict quality and regulatory standards. The position requires standing for the full shift, working with chemicals, and supporting production demands through overtime when needed.

Responsibilities

• Operate machinery and equipment to produce medical devices according to defined specifications and quality standards.
• Formulate polymers and prepare spray coating and excipient formulations in line with established procedures.
• Set up coating machines, perform coating operations, and ensure consistent and accurate application on balloon catheters.
• Inspect products using a microscope to verify quality, dimensions, and adherence to specifications.
• Fold, assemble, and build balloon catheters and related components required for top-level work orders.
• Prepare products for sterilization, including packaging sterile and non-sterile finished goods and semi-finished goods.
• Follow detailed manufacturing instructions and accurately update all job documentation to ensure full traceability.
• Perform testing of formulations and document results according to Good Manufacturing Practices (GMPs).
• Identify and report supplies and materials that need to be replenished to avoid production delays.
• Complete required cleaning activities to maintain a cleanroom and controlled environment, including equipment and work areas.
• Adhere to cleanroom gowning and de-gowning procedures to maintain aseptic conditions.
• Comply with all GMP, safety, and quality procedures, including safe handling of chemicals and materials.
• Support production demands by working overtime and weekends as needed to meet customer and operational requirements.

Essential Skills

• High school diploma or equivalent education.
• At least 1 year of experience in the medical device industry, ideally in a manufacturing or assembly environment.
• Familiarity with cleanroom operations, including gowning and de-gowning processes.
• Ability and willingness to stand for the entire shift.
• Comfort working with chemicals in a controlled environment.
• Proficiency in English at a medium level to read, understand, and follow manufacturing instructions and documentation.
• Experience operating manufacturing equipment and machinery in a regulated environment.
• Ability to follow Good Manufacturing Practices (GMPs) and standard operating procedures accurately.
• Willingness to work overtime and weekends as required to support production needs.

Additional Skills & Qualifications

• Experience with microscope inspection in a production or quality environment.
• 1+ year of medical device manufacturing experience with microscope use is strongly preferred.
• Experience working in a cleanroom setting with strict cleanliness and contamination control requirements.
• Attention to detail and strong documentation skills for accurate completion of batch records and job documentation.
• Ability to work effectively in a fast-paced, highly regulated production environment.

Why Work Here?

You will join a growing operation that is supporting a medical device product working toward FDA approval in the United States, offering the opportunity to contribute to life-enhancing technologies at an early and exciting stage. The environment emphasizes quality, regulatory excellence, and professional development, giving you the chance to deepen your experience in cleanroom manufacturing and medical device production. As part of a busy and expanding team, you can build valuable skills, gain exposure to advanced processes, and grow your career in a stable and impactful industry.

Work Environment

You will work primarily in a cleanroom environment with strict gowning and de-gowning procedures and aseptic practices. The role requires standing for the full shift and working with chemicals, polymers, and spray coating formulations while operating coating machines, microscopes, and other production equipment. The schedule is a 1st shift position with the expectation of overtime and weekend work during periods of high demand. The shift structure includes two 30-minute breaks: one unpaid lunch break and one paid break, instead of shorter breaks spread throughout the day. The facility follows Good Manufacturing Practices (GMPs) and emphasizes cleanliness, safety, and adherence to detailed procedures in all production activities.

Job Type & Location

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

Pay and Benefits

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

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 benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Jun 19, 2026.