Job Summary We are seeking a detail-oriented and highly skilled Cleanroom Assembler to join our innovative biomedical manufacturing team. In this role, you will be responsible for precision assembly of medical devices within a controlled cleanroom environment, ensuring adherence to strict quality standards and regulatory requirements. Your expertise will contribute directly to the production of life-saving medical equipment, supporting our mission to improve patient outcomes worldwide. This position offers an engaging opportunity to work in a fast-paced, safety-conscious setting where attention to detail and technical proficiency are paramount. Responsibilities Perform manual and mechanical assembly of medical devices following detailed manufacturing standard operating procedures (SOPs) and work instructions. Utilize hand tools, calipers, micrometers, and microscopes to measure and verify component dimensions with high precision. Interpret technical drawings, blueprints, and production documents accurately to ensure correct assembly processes. Maintain compliance with

ISO 13485

standards, FDA regulations, GMP (Good Manufacturing Practices), and cleanroom protocols to uphold product quality and safety. Conduct quality inspections throughout the assembly process, identifying defects or deviations using visual inspection techniques and measurement tools. Package finished products according to packaging specifications while ensuring contamination control within the cleanroom environment. Document all manufacturing activities meticulously, including inspection results, process deviations, and production logs for traceability and audit purposes. Qualifications Proven experience in biomedical manufacturing processes or medical device assembly within a cleanroom setting. Strong mechanical knowledge with proficiency in using hand tools, calipers, micrometers, and microscopes for precision measurement. Familiarity with interpreting technical drawings, blueprints, and manufacturing documentation. Knowledge of

GMP, ISO 13485

standards, FDA regulations, and cleanroom protocols is essential. Experience with plastics injection molding, soldering, or packaging is a plus. Ability to perform manual assembly tasks accurately while maintaining high attention to detail in a fast-paced environment. Basic math skills necessary for measurements and calculations related to component specifications. Prior quality assurance experience within manufacturing environments is highly desirable. Join us as a Cleanroom Assembler and become part of a dedicated team committed to producing high-quality medical devices that make a real difference in people's lives!

Pay:

$20.00 - $22.00 per hour Expected hours: No less than 40.0 per week

Benefits:

401(k) Dental insurance Health insurance

Work Location:

In person