Job ID Number
R5813
Employment Type
Full time
Worksite Flexibility
Onsite
Job Summary
As Assembly Operator, you will be responsible for assembling various medical device components and products according to strict procedures and quality standards.
Job Description
We are looking for a Assembly Operator. This position will be a full-timeand onsite contract opportunity in Plymouth, MN. The work schedule for this role will be 4:30AM – 3PM, Monday – Thursday.
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.
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
Adhere to client's values of Integrity, Accountability, Teamwork, Innovation, and Inclusion
Required
Ability to read, understand, and follow complex work instructions and product specifications
Strong attention to detail and commitment to quality
Good hand-eye coordination and manual dexterity
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
Preferred
High school diploma or equivalent
Previous experience in medical device assembly or related healthcare product manufacturing
Familiarity with FDA regulations and ISO 13485 standards for medical devices
Experience using specialized tools and equipment for medical device assembly
Knowledge of clean room protocols and contamination control procedures
Basic computer skills for data entry and record-keeping in a regulated environment
Ability to lift up to 25 pounds occasionally
Capable of sitting or standing for extended periods
Excellent near vision (with or without correction) for detailed medical device assembly work
Ability to wear clean room attire for extended periods
Climate-controlled, clean room manufacturing facility
May involve exposure to moderate noise levels
Shift work may be required, including possible overtime
Fast-paced, highly regulated medical device production environment
The pay range for this position is $18.00 per hour (USD). Exact compensation may vary based on several factors, including location, experience, and education. Benefit packages for this role will include medical coverage as well as 401k retirement account access. Employees in this role may also be entitled to paid sick leave and/or other paid time off as provided by applicable law.
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 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.