Production Operator Assembler I

Key Responsibilities

• Perform visual and/or dimensional inspection using microscopes, gauges, calipers, or other measurement tools.
• Complete required documentation such as production records, quality checks, setup sheets, and history records.
• Handle and work with cleaning chemicals such as isopropyl alcohol, detergents, or solvents.
• Maintain an organized, clean work area following 5S expectations.
• Participate in required training and company meetings.
• Read, understand, and follow work instructions, standard work, and applicable quality/ISO/cGMP requirements.
• Crosstrain across manufacturing areas.
• Support and comply with the Quality System, ISO, and medical device regulatory requirements.
• Communicate issues with materials, equipment, or processes promptly.
• Perform other duties as assigned.

Assembly Responsibilities

• Inspect, assemble, and/or package components and medical devices per customer specifications.
• Operate hand tools and basic manual equipment used in the assembly process.
• Use sealing equipment such as tray, band, or impulse sealers.
• Perform labeling, packaging, and final presentation of product.

Production Operations Responsibilities

• Operate production equipment or machines per work instructions, ensuring correct materials, tooling, programs, and processes are used.
• Monitor production processes, part quality, and machine performance.
• Perform basic preventive or operator-level machine checks (e.g., cleanliness, safe operation).

Secondary Operations Responsibilities

• Perform secondary operations such as trimming, deburring, cleaning, laser marking, laser welding and/or finishing of components.
• Operate designated secondary equipment or simple mechanical devices.
• Inspect and verify part conformance after secondary operations.
• Use basic measurement tools to ensure accuracy (gauge pins, calipers, tape measures).

Requirements & Tech Stack

• Ability to work in a manufacturing environment.
• Ability to read, write, and follow written instructions in English.
• Perform basic math, hand–eye coordination, and dexterity.
• Ability to use basic hand tools and measurement equipment.
• Clear and effective verbal and written communication skills.
• Strong attention to detail and organizational skills.
• Ability to work in a fast-paced team environment and handle multiple tasks.
• Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).

Qualifications

• High school diploma or equivalent (Desirable).
• 6+ months of manufacturing, assembly, machine operation, or cleanroom experience (Desirable).
• Familiarity with FDA, ISO, cGMP, Lean manufacturing, or workplace safety practices (Desirable).
• Experience working with microscopes or inspection tools (Desirable).