CAI

Job ID Number

R5444

Employment Type

Full time

Worksite Flexibility

Onsite

Job Summary

As an Assembly Operator, you will operate assigned automated assembly machinery, ensure component flow, troubleshoot and correct machinery issues to ensure quality and productivity.

Job Description

We are looking for an Assembly Operator. This position will be full-time contract and on-site in Plymouth, Minnesota.

Shift: Monday-Thursday 10 hours

4:30AM-3PM with Occasional OT on Friday/Saturday

This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.

What You’ll Do

• Assemble medical device components and products according to detailed work instructions, specifications, and FDA regulations
• Operate specialized medical device assembly equipment and tools safely and efficiently
• Perform visual inspections and quality checks on assembled medical products, ensuring compliance with stringent medical standards
• Maintain a clean room environment, adhering to strict cleanliness and contamination control protocols
• Follow all safety procedures and Good Manufacturing Practices (GMP) guidelines
• Report any quality issues, deviations, or equipment malfunctions to supervisors immediately
• Work collaboratively with team members to meet production goals while maintaining the highest quality standards
• Participate in continuous improvement initiatives and suggest process enhancements
• Maintain accurate records of completed work, production data, and traceability documentation

What You'll Need

Required:

• High School Diploma or GED Required
• Previous experience in medical device assembly or related healthcare product manufacturing
• Experience using specialized tools and equipment for medical device assembly
• Basic computer skills for data entry and record-keeping in a regulated environment
• Ability to work in a clean room environment and wear appropriate personal protective equipment (PPE)
• Willingness to work in a regulated medical device manufacturing environment
• Basic math skills for measuring and counting components
• Commitment to safety and quality standards in medical device production
• Ability to lift up to 25 pounds occasionally
• Capable of sitting or standing for extended periods

Preferred:

• Familiarity with FDA regulations and ISO 13485 standards for medical devices
• Knowledge of clean room protocols and contamination control procedures

Physical Demands

• Ability to safely and successfully perform the essential job functions consistent with the ADA and other federal, state, and local standards
• Sedentary work that involves sitting or remaining stationary most of the time with occasional need to move around the office to attend meetings, etc.
• Ability to conduct repetitive tasks on a computer, utilizing a mouse, keyboard, and monitor

Reasonable Accommodation Statement

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employment selection process, please direct your inquiries to application.accommodations@cai.io or (888) 824 – 8111.

Equal Employment Opportunity Policy Statement

CAI is committed to equal employment opportunity. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or veteran status. All employment decisions are based on valid job requirements, including hiring, promotion, and compensation. Harassment and retaliation are prohibited.