Assembler

Job Title: Medical Device Production Technician

Job Description

This role is responsible for producing high-quality medical devices in a cleanroom environment, including the formulation of polymers and spray coating solutions, operation of specialized machinery and microscopes, and preparation of sterile and non-sterile products in compliance with Good Manufacturing Practices (GMPs).

Responsibilities

• Operate coating machines and other production machinery to manufacture medical devices according to defined specifications and quality standards.
• Formulate polymers, excipient solutions, and spray coating formulations following established procedures.
• Set up, adjust, and monitor coating machines and related equipment to ensure consistent and accurate production.
• Inspect products using a microscope to verify quality, dimensions, and overall integrity of components and finished devices.
• Coat, inspect, and fold balloon catheters and other components as required by production orders.
• Prepare and package sterile and non-sterile finished goods and semi-finished goods in accordance with GMPs and internal procedures.
• Follow detailed manufacturing instructions and accurately complete all required job documentation to maintain full traceability.
• Build components required for top-level work orders and ensure materials are ready for subsequent assembly steps.
• Identify and report supplies and materials that need replenishment to avoid production delays.
• Perform testing of formulations and document results in line with quality requirements.
• Complete routine and assigned cleaning activities to maintain cleanroom and equipment cleanliness standards.
• Work safely with chemicals and follow all safety protocols, including proper handling, labeling, and disposal.
• Support aseptic and cleanroom practices, including correct gowning and de-gowning procedures.
• Participate in overtime and weekend work as needed to support production demands.

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.
• Experience working in a cleanroom environment, including familiarity with gowning and de-gowning procedures.
• Ability and willingness to stand for the entire shift.
• Medium-level proficiency in English with the ability to read, understand, and follow written manufacturing instructions and complete documentation accurately.
• Comfort working with chemicals and following safety procedures.
• Experience with microscope inspection, preferably 1+ year in medical device manufacturing using a microscope.
• Understanding of Good Manufacturing Practices (GMPs) and their application in a regulated production setting.
• Willingness to work overtime and weekends to support production needs.
• Ability to follow detailed instructions and maintain high attention to detail in a cleanroom and aseptic environment.

Additional Skills & Qualifications

• Prior experience in medical device assembly, especially involving balloon catheters, is an advantage.
• Experience in pharmaceutical, aseptic, or formulation work is beneficial.
• Experience with product packing and sterilization preparation is preferred.
• Familiarity with operating various production equipment and machinery used in medical device manufacturing.
• Strong documentation and record-keeping skills to ensure traceability and compliance.
• Ability to work effectively in a team-oriented production environment and adapt to changing priorities.

Why Work Here?

You join a growing organization with a strong focus on innovation in medical technology, where the product pipeline includes a device working toward FDA approval in the United States. The company offers the opportunity to contribute directly to life-improving medical solutions while gaining hands-on experience in a regulated, high-tech environment. You benefit from a culture that values quality, continuous improvement, and professional growth, with the chance to build your skills in cleanroom manufacturing, formulation, and advanced inspection techniques.

Work Environment

This role is based primarily in a cleanroom environment that follows strict GMP and aseptic standards. You will wear appropriate cleanroom attire and follow gowning and de-gowning procedures to maintain product and environmental integrity. The work involves standing for the entire shift and regularly using microscopes, coating machines, and other specialized production equipment. You will handle chemicals and formulations while adhering to safety protocols. The schedule includes the possibility of overtime and weekend work to support high production demand. Breaks typically include one 30-minute off-the-clock lunch break and one 30-minute on-the-clock break in place of shorter breaks, providing structured rest periods during the shift.

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 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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Sep 24, 2026.

About Aerotek

Aerotek® Inc. provides staffing and services solutions in manufacturing, logistics, construction, aviation, facilities and maintenance. We provide the expertise, solutions and people required to rise to the challenges of North American industry. Headquartered in Hanover, Md., Aerotek operates a unified network of over 200 offices across North America, supporting more than 18,000 clients each year. Aerotek is an Allegis Group company, the global leader in workforce and business solutions. To learn more, visit: Aerotek.com | 1-888-AEROTEK.

Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.