Manufacturing Device Operator

About the Role

Performs a variety of tasks involved in the manufacturing and assembly of medical devices in a regulated production environment. The Manufacturing Operator is trained on all assigned tasks and is responsible for following established written procedures and work instructions to ensure product quality and compliance.

Responsibilities

• Safety & Compliance
  • Adhere to all established safety policies and procedures; unsafe behavior will result in corrective action.
  • Comply with all Good Manufacturing Practices (GMP), regulatory requirements, and company policies.
  • Maintain a strong safety-first mindset at all times.
• Quality & Work Execution
  • Follow written work instructions and standard operating procedures for all assigned tasks.
  • Perform only those operations for which required training has been completed and documented.
  • Conduct product inspections using visual standards and basic measurement tools in accordance with procedures.
  • Accurately document and record production and quality data as required.
  • Immediately report deviations, nonconformances, or abnormal conditions to supervision.
• Workplace Standards & Collaboration
  • Maintain a clean, organized, and orderly work area in accordance with 5S principles.
  • Contribute to a positive work environment through effective communication and teamwork.
  • Support continuous improvement efforts to enhance product quality and operational efficiency.
  • Participate in cross-training and job rotation as assigned.
  • May assist in training new or less experienced employees as needed.
• Flexibility & Operations Support
  • Remain flexible and willing to support reassignment or job rotation based on production needs.
  • Follow direction from supervision to support changing priorities and production schedules.

Requirements

• High school diploma or GED preferred.
• Previous experience in medical device or regulated manufacturing environment preferred, but not required.
• Ability to read, understand, and follow written and verbal instructions.
• Ability to communicate effectively in a production environment.
• Ability to perform basic mathematical functions including addition, subtraction, multiplication, division, fractions, and decimals.
• Ability to apply common sense understanding to follow written, verbal, and visual instructions.
• Ability to recognize deviations and escalate appropriately.

Physical Demands

• Frequent use of hands to handle, assemble, and inspect small components.
• Regular lifting and/or moving of up to 30 lbs.
• Ability to perform close visual inspection of product and components.
• Must be able to stand, sit, or perform repetitive tasks for extended periods as required.

Work Environment

• Work performed in a controlled manufacturing environment, which may require PPE such as hairnets, beard covers, smocks, and gloves.
• Restrictions on personal items such as makeup and jewelry may apply in controlled areas.
• Exposure to low levels of solvents or solvent odors may occur, not requiring respiratory protection beyond safety glasses.
• Additional personal protective equipment may be required depending on assigned tasks.