Cleanroom Assembler

Cleanroom Assembler

The Cleanroom Assembler operates and maintains small production equipment in a controlled cleanroom environment to produce high-quality medical devices. This role focuses on small component assembly under a microscope, light soldering, and precise inspection work while strictly following documentation, Good Manufacturing Practice (GMP), and quality assurance standards. The position requires strong attention to detail, manual dexterity, and the ability to work independently while contributing positively to a collaborative production team.

Responsibilities

• Operate and maintain small production equipment safely and efficiently to produce high-quality products.
• Perform small component assembly under a microscope, including light soldering, to build medical devices to specification.
• Complete component assembly, inspection, and related production duties in accordance with established procedures.
• Meet all documentation requirements by accurately completing and filing paperwork, records, and product-related documents.
• Maintain a clean and organized work area to support cleanroom and production standards.
• Execute all production processes for spherz products, including forming, cutting, punching, assembly, packaging, and sealing.
• Follow established documentation requirements and GMP standards throughout the entire production process.
• Inspect, evaluate, and accept products in line with documented quality assurance standards and procedures.
• Read and interpret blueprints and related documentation to ensure correct assembly and inspection.
• Operate packaging machinery and other production equipment as needed within the cleanroom environment.
• Work with robotics and automated machines in the cleanroom to support hands-on component assembly and inspection.
• Adhere to cleanroom protocols and GMP regulations at all times to maintain product integrity and compliance.
• Collaborate effectively with team members and contribute to a positive, high-performing production environment.
• Work independently and remain productive without constant supervision, consistently meeting quality and output expectations.

Essential Skills

• Demonstrated experience in assembly, production operation, machine operation, or general manufacturing.
• Experience working in a GMP environment or similar regulated production setting.
• Strong attention to detail, especially when working with small components and precision assemblies.
• Proficiency in component assembly using microscopes and other inspection tools.
• Ability to perform light soldering tasks as part of small component assembly.
• Manual and hand dexterity for fine motor tasks such as medical device assembly and deburring.
• Ability to read and interpret blueprints and follow detailed work instructions.
• Experience with inspection processes and quality checks to ensure products meet QA standards.
• Capability to operate production equipment, packaging machinery, and cleanroom machinery safely and accurately.
• Comfort working in a cleanroom environment and willingness to learn and follow GMP regulations.
• Strong documentation skills, including accurately completing and filing paperwork and production records.
• Ability to work independently, stay focused, and maintain productivity without direct supervision.
• Strong work ethic and reliable, consistent performance in a team-based production environment.

Additional Skills & Qualifications

• Experience in medical device manufacturing or medical assembly.
• Familiarity with cleanroom operations and cleanroom gowning procedures.
• Experience using microscopes for assembly and inspection tasks.
• Knowledge of IPC and J-STD standards for soldering and electronic assembly.
• Experience working with robotics or automated machines in a production environment.
• Mechanical aptitude and comfort with hands-on assembly and machine operation.
• Experience in inspection, deburring, and finishing of small components.
• Exposure to production environments that require strict adherence to quality and documentation standards.

Why Work Here?

This organization is experiencing significant growth and offers a stable, expanding environment with strong opportunities for development. The company has rapidly…