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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-time** and **onsite contract opportunity in Plymouth, MN.** **The w** **ork 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.

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

+ Adhere to client's values of Integrity, Accountability, Teamwork, Innovation, and Inclusion

What You'll Need

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

Physical Demands

+ 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 [email protected] 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.