Cleanroom Assembler Human Bees Hayward, CA Job Details Full-time $20 - $21 an hour 20 hours ago Qualifications Inspection gauge Mechanical blueprint interpretation Measurement-based inspection Assembly quality control testing Quality records maintenance Schematics Safety protocol adherence Medical device testing ISO standards Efficiency improvement Monitoring dimensions Regulatory compliance Contamination control Machine troubleshooting Cleanroom protocols Mid-level Inspection reporting and documentation Shop math Factory operations documentation Manual packaging Manufacturing standard operating procedures Manufacturing facility experience Mechanical drawings Dimensional measurements Medical device manufacturing facility experience Quality assurance standard operating procedures Cleanroom gowning procedures Precision measurement in machining Compliance documentation Visual inspection as testing technique Full Job Description Overview We are seeking a meticulous and dedicated Cleanroom Assembler to join our advanced biomedical manufacturing team. In this role, you will be responsible for assembling medical devices within a controlled cleanroom environment, adhering strictly to industry standards and regulatory requirements. The ideal candidate will possess a strong mechanical aptitude, proficiency with precision tools, and experience working in cleanroom settings that comply with

ISO 13485, FDA

regulations, and GMP standards. Your contributions will directly impact the quality and safety of life-saving medical products, supporting our mission to deliver innovative healthcare solutions. Duties Perform manual and mechanical assembly of medical devices in a cleanroom environment following detailed manufacturing standard operating procedures (SOPs). Interpret technical drawings, assembly instructions, and production documents accurately to ensure precise component placement. Use precision measurement tools such as calipers, micrometers, and microscopes to verify dimensions and tolerances during assembly. Maintain strict adherence to cleanroom protocols, including proper gowning procedures and contamination control measures. Conduct quality inspections throughout the assembly process to identify defects or deviations using visual inspection techniques and quality assurance standards. Package finished products according to specified packaging protocols while ensuring compliance with cleanliness standards. Document all assembly activities accurately in production records, including measurements, inspection results, and any deviations observed. Collaborate with quality assurance teams to support audits, process improvements, and compliance with regulatory requirements such as ISO 13485 and FDA regulations. Assist in troubleshooting mechanical issues or assembly challenges by utilizing mechanical knowledge and hand tools effectively. Support continuous improvement initiatives by providing feedback on manufacturing processes and suggesting enhancements for efficiency. Experience Prior experience working within a medical device manufacturing facility or biomedical manufacturing environment is highly preferred. Demonstrated proficiency in cleanroom protocols and GMP (Good Manufacturing Practice) standards. Hands-on experience with manual assembly techniques involving small components and intricate parts. Familiarity with interpreting technical drawings, blueprints, or schematics related to medical devices. Experience utilizing measurement tools such as calipers, micrometers, and microscopes for quality inspection purposes. Knowledge of

ISO 13485

standards governing medical device quality management systems. Strong understanding of manufacturing documentation processes and the importance of accurate record keeping. Ability to work effectively within a team while maintaining high attention to detail in a fast-paced environment. Basic math skills necessary for measurements, calculations, and documentation accuracy. Mechanical aptitude complemented by experience using hand tools for assembly tasks. Join our team as a Cleanroom Assembler to contribute meaningfully to the development of life-enhancing medical devices. Your precision skills and commitment to quality will help ensure the safety and efficacy of our products while supporting advancements in healthcare technology.

Pay:

$20.00 - $21.00 per hour

Work Location:

In person