Manufacturing Device Operator

Aptyx; Fenimore (NY); On-site; USD 35,000 - 50,000; Full time

Job summary

Aptyx, located in Fenimore, New York, is seeking a Manufacturing Operator to join our team in a regulated environment. This role involves performing various tasks related to the assembly and manufacturing of medical devices, ensuring compliance with all safety and quality standards.

The ideal candidate should have strong attention to detail, effective communication skills, and the ability to follow written instructions. A high school diploma or GED is preferred, along with experience in a regulated manufacturing environment.

Qualifications

• Ability to read, understand, and follow written and verbal instructions.
• Ability to perform basic mathematical functions including addition, subtraction, multiplication, division, fractions, and decimals.
• Prior experience in a regulated manufacturing environment is an advantage.

Responsibilities

• Perform various tasks in the manufacturing and assembly of medical devices.
• Comply with Good Manufacturing Practices, safety policies, and quality requirements.
• Conduct product inspections and document production data accurately.
• Maintain a clean and organized work area while contributing to teamwork.

Skills

Ability to follow written instructions

Communication skills

Basic mathematical skills

Attention to detail

Education

High school diploma or GED preferred

Experience in medical device manufacturing preferred

Job description

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

• 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 elevate 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

I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.

Employee Signature

Date