Operator​/Machine Operator​/Assembler​/Cleanroom

Operator I Medical Device Assembly

Location: New Brighton (St. Paul), MN

We are seeking a detail-oriented Operator I to support the assembly, inspection, testing, and packaging of medical devices in a cleanroom manufacturing environment. This role requires adherence to quality standards, SOPs, and GMP/FDA regulations while producing high-quality medical device products.

• Assemble medical device components according to established procedures and work instructions.
• Perform visual inspections and functional testing of products.
• Conduct periodic microscope work for detailed inspections.
• Package and box finished products for shipment.
• Operate assembly tools including electrical torque drivers and screwdrivers.
• Follow cleanroom protocols and wear required PPE (hair net, beard net, shoe covers, safety glasses, etc.).
• Complete production documentation accurately and maintain compliance with quality requirements.
• Participate in cross‑training opportunities across multiple production areas.
• Follow SOPs, GMP, FDA, and safety requirements at all times.
• Maintain a clean and organized work environment.

• High School Diploma or GED required.
• 1 3 years of experience in a medical device manufacturing environment.
• Previous cleanroom experience is required.
• Hands‑on assembly experience within the medical device industry.
• Ability to read, write, and communicate effectively in English.
• Ability to understand and follow SOPs, GMP, and FDA-regulated processes.
• Strong attention to detail and manual dexterity.

• Experience using microscopes for inspection work.
• Soldering experience.
• Experience with testing and troubleshooting medical device products.
• Familiarity with quality systems and documentation practices.

• Medical device cleanroom environment.
• Required PPE and gowning procedures.
• Standing, repetitive hand movements, and handling small components.
• Overtime may be required based on production needs.