Job Summary We are seeking a dedicated Medical Assembler Operator to join our manufacturing team in the production of high-precision medical devices. This role involves manual and mechanical assembly of medical components within a regulated cleanroom environment, ensuring compliance with industry standards such as

ISO 13485, FDA

regulations, and GMP protocols. The ideal candidate will possess strong mechanical aptitude, proficiency with hand tools and measurement instruments like calipers and micrometers, and experience interpreting technical drawings and manufacturing documentation. This position offers an opportunity to contribute to life-saving medical products while maintaining rigorous quality standards. Duties Perform manual and mechanical assembly of medical device components in accordance with detailed work instructions and standard operating procedures. Utilize precision measurement tools such as calipers, micrometers, and microscopes to verify component dimensions and ensure adherence to specifications. Interpret technical drawings, manufacturing documents, and assembly instructions accurately to facilitate correct assembly processes. Maintain a cleanroom protocol by following strict cleanliness, gowning, and contamination control procedures throughout all tasks. Conduct quality inspections at various stages of assembly to identify defects or deviations, documenting findings per quality assurance protocols. Use hand tools effectively for assembly, disassembly, and adjustments while adhering to safety guidelines. Package finished products carefully for shipment, ensuring compliance with packaging standards and documentation requirements. Support continuous improvement initiatives by providing feedback on assembly processes and suggesting enhancements for efficiency or quality. Skills Proficiency with measurement instruments including calipers, micrometers, and microscopes. Strong understanding of

ISO 13485

standards, FDA regulations, GMP, and CGMP manufacturing practices. Experience in biomedical manufacturing processes and cleanroom protocols. Mechanical knowledge coupled with manual assembly skills for precise component handling. Ability to interpret technical drawings, manufacturing SOPs (Standard Operating Procedures), and production documents. Familiarity with medical device assembly within a regulated manufacturing environment. Basic math skills necessary for measurements, calculations, and documentation accuracy. Prior experience in quality assurance within manufacturing settings is highly desirable. Competence in using hand tools safely and effectively during assembly tasks. Knowledge of packaging requirements for sterile or sensitive medical products. This role is vital in supporting the production of reliable medical devices that meet stringent industry standards. We welcome candidates committed to precision craftsmanship, quality assurance excellence, and contributing to healthcare advancements worldwide.

Pay:

$20.00 per hour Expected hours: 40.0 per week

Benefits:

Health insurance

Work Location:

In person