Manufacturing Device Operator

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.

Performance will be evaluated based on quality, productivity, attendance, adherence to company policies and procedures, compliance with regulatory and safety requirements, and overall contribution to team objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Safety & Compliance

Aptyx places the highest priority on employee safety. All employees are responsible for maintaining a safe work environment and adhering to all established safety policies and procedures. Unsafe behavior or failure to comply with safety requirements will result in corrective action.

• Comply with all Good Manufacturing Practices (GMP), regulatory requirements, and company policies and procedures


• Follow all plant safety policies and 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 in the training matrix


• 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

SUPERVISORY RESPONSIBILITIES

• None

QUALIFICATION REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made for individuals with disabilities.

Education & Experience

• High school diploma or GED preferred


• Previous experience in medical device or regulated manufacturing environment preferred, but not required

Language Skills

• Ability to read, understand, and follow written and verbal instructions


• Ability to communicate effectively in a production environment

Mathematical Skills

• Ability to perform basic mathematical functions including addition, subtraction, multiplication, division, fractions, and decimals

Reasoning Ability

• 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

Acknowledgement