Laser Marking Operator-2nd Shift

Position Summary

The Laser Marking Operator is responsible for operating and maintaining laser marking equipment used to permanently mark medical device components in accordance with engineering specifications, customer requirements, and regulatory standards. This role ensures product traceability through accurate laser engraving of part numbers, lot numbers, UDI (Unique Device Identification), logos, and other required markings while maintaining the highest standards of quality, safety, and efficiency. The Laser Marking Operator performs inspections, completes production documentation, and supports continuous improvement initiatives in a regulated medical device manufacturing environment.

Essential Duties and Responsibilities

• Set up, operate, and monitor laser marking equipment to produce high-quality, permanent markings on medical device components.
• Load and unload parts while maintaining proper part orientation and fixture alignment.
• Verify laser marking programs and ensure correct revision levels are being used.
• Perform first article, in-process, and final inspections to verify marking quality, readability, and location.
• Inspect parts using microscopes, vision systems, magnification equipment, and precision measuring devices.
• Ensure compliance with customer drawings, work instructions, manufacturing travelers, and quality standards.
• Perform barcode and UDI verification using approved verification equipment when required.
• Maintain complete and accurate production records, inspection results, and device history documentation.
• Identify and segregate nonconforming products according to company procedures.
• Troubleshoot minor equipment issues and notify maintenance or engineering of recurring problems.
• Perform routine cleaning and preventive maintenance of laser marking equipment.
• Maintain proper material identification and traceability throughout the manufacturing process.
• Follow Good Manufacturing Practices (GMP), FDA regulations, ISO 13485 requirements, and company quality procedures.
• Adhere to all safety policies, including laser safety protocols and the use of required personal protective equipment (PPE).
• Support continuous improvement initiatives focused on quality, efficiency, and waste reduction.
• Cross-train in other manufacturing operations as needed.

Qualifications

Education

• High school diploma or GED required.
• Technical certification in manufacturing, machining, or electronics preferred.

Experience

• 1–3 years of manufacturing experience preferred.
• Experience operating laser marking or laser engraving equipment is highly preferred.
• Experience in a medical device, aerospace, electronics, or precision manufacturing environment is preferred.
• Experience working in a regulated manufacturing environment is a plus.

Required Knowledge, Skills, and Abilities

• Ability to operate laser marking systems safely and efficiently.
• Ability to read and interpret engineering drawings, blueprints, and work instructions.
• Basic understanding of GD&T (Geometric Dimensioning & Tolerancing) preferred.
• Knowledge of UDI marking requirements is a plus.
• Strong attention to detail with the ability to identify cosmetic and dimensional defects.
• Experience using microscopes, vision systems, and inspection equipment.
• Ability to use precision measuring tools such as:
  • Calipers
  • Micrometers
  • Optical comparators
  • Vision inspection systems
• Basic computer skills, including production software and Microsoft Office.
• Ability to perform basic troubleshooting and identify process abnormalities.
• Excellent organizational and documentation skills.
• Ability to work independently and as part of a team.

Physical Requirements

• Ability to sit or stand for extended periods.
• Frequent use of hands for handling small precision components.
• Good manual dexterity and hand-eye coordination.
• Ability to lift up to 30 pounds occasionally.
• Ability to distinguish fine details using magnification equipment.
• Ability to work in a cleanroom or controlled manufacturing environment when required.

Work Environment

• Manufacturing environment with laser marking equipment.
• Exposure to moving mechanical equipment and precision manufacturing processes.
• PPE required, including safety glasses and other protective equipment as necessary.
• Compliance with laser safety procedures is mandatory.
• May require overtime or weekend work to meet production schedules.

Preferred Experience

Candidates with experience operating or working around the following equipment are encouraged to apply:

• Keyence Laser Marking Systems
• Telesis Laser Markers
• Trumpf Laser Systems
• Fiber Laser Marking Equipment
• Vision Inspection Systems
• Barcode/UDI Verification Systems

Key Performance Indicators (KPIs)

• Production output meets daily scheduling requirements.
• First-pass yield and quality acceptance rates.
• Accurate UDI and product traceability compliance.
• Minimal scrap and rework.
• On-time completion of production orders.
• Accurate documentation and production records.
• Compliance with FDA, ISO 13485, GMP, and internal quality standards.