Assembler II & III , Medical Device Manufacturing s + weekends

Job Description

Medical Device Assembler II and III – Irvine, CA
Contract-to-Hire
Pay: $24 to $27/hr depending on experience+ shift

Multiple Schedules Available:

• 1st shift:
  Monday – Thursday, 5:00 AM - 3:30 PM
• 2nd Shift: Monday – Thursday, 3:30 PM - 2:00 AM + 5% shift differential
• Weekend Shift: Friday – Sunday, 5:00 AM - 5:00 PM + 7% shift differential (training on 1st shift for a couple of weeks)
• 4th Shift/ Weekend:
  Friday – Sunday, 5:00 PM - 5:30 AM + 7% shift differential (training on 1st shift for a couple of weeks)

Position Summary
A leading medical-device implant manufacturer in Irvine is seeking experienced Assembler II and Assembler III candidates to support the production of insulin-pump implants. These positions perform detailed, precision assembly under a microscope in a regulated cleanroom environment.

The ideal candidates are dependable, detail-oriented, comfortable working with small and delicate components, and capable of consistently producing high-quality work while meeting production deadlines.

Essential Duties and Responsibilities

• Perform precision assembly of medical-device components using a microscope.
• Follow approved manufacturing procedures, work instructions, engineering drawings, and inspection procedures.
• Comply with Good Manufacturing Practices, FDA regulations, ISO 13485 requirements, and medical-device quality standards.
• Follow company Standard Operating Procedures and departmental policies and procedures.
• Inspect completed work for accuracy, workmanship, defects, and compliance with specifications.
• Accurately complete required production and quality documentation.
• Learn new equipment and manufacturing processes and quickly demonstrate proficiency.
• Maintain a clean, organized, and safe work area.
• Wear required personal protective equipment and follow all cleanroom protocols.
• Monitor personal work to ensure accuracy, completeness, and consistent quality.
• Communicate effectively and work collaboratively with production, quality, engineering, and management teams.
• Meet production schedules and deadlines while maintaining strict quality standards.
• Perform additional production-related duties as assigned.

Assembler II Qualifications

• At least three years of related medical-device production assembly experience.
• Experience working in a medical-device manufacturing environment.
• Experience with microscope assembly and cleanroom procedures.
• Experience in an FDA-, GMP-, or ISO-regulated environment preferred.
• Ability to read and understand manufacturing procedures, work instructions, engineering drawings, and inspection requirements.
• Strong attention to detail and commitment to quality.

Pay: $24/hour

Assembler III Qualifications

• At least five years of related medical-device production assembly experience.
• At least five years of experience working in a medical-device manufacturing environment.
• Advanced precision assembly experience using a microscope in a cleanroom.
• Experience working under FDA, GMP, and ISO quality requirements preferred.
• Ability to independently read and interpret manufacturing procedures, engineering drawings, work instructions, and inspection procedures.
• Demonstrated ability to produce consistently accurate, high-quality work.
• Strong problem-solving, communication, organizational, and teamwork skills.

Pay: $25–$27/hour, depending on experience

Additional Requirements

• Ability to read, write, and understand work instructions and documentation written in English.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to meet deadlines and work effectively in a team environment.
• Willingness to wear all required personal protective equipment.
• Flexibility to work overtime when needed.

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