Medical Device Assembler

Overview We are seeking a dedicated Medical Device Assembler to join our manufacturing team. This role involves assembling, inspecting, and packaging medical devices in a controlled environment to ensure compliance with strict quality standards and regulatory requirements. The ideal candidate will possess mechanical aptitude, attention to detail, and familiarity with industry regulations such as ISO 13485 and FDA standards. This position offers an opportunity to contribute to the production of high-quality medical equipment that improves patient care worldwide. Duties Assemble medical devices using hand tools, calipers, micrometers, and other precision measuring instruments to ensure accurate fit and function. Follow detailed work instructions and standard operating procedures (SOPs) aligned with

ISO 13485, FDA

regulations, and CGMP (Current Good Manufacturing Practice) standards. Conduct thorough inspections of components and finished products for defects or inconsistencies, ensuring compliance with quality specifications. Operate cleanroom equipment and maintain a sterile environment during assembly and packaging processes. Utilize plastics injection molding techniques where applicable for component fabrication or modification. Perform soldering tasks on electronic components following safety protocols and technical specifications. Package finished products carefully to prevent damage during shipping, adhering to proper labeling and documentation procedures. Maintain accurate records of production activities, inspections, and deviations in accordance with regulatory requirements. Support continuous improvement initiatives by identifying potential process enhancements or quality issues. Collaborate with engineering and quality assurance teams to resolve assembly challenges efficiently. Skills Proficiency in using calipers, micrometers, hand tools, and other precision measurement devices. Knowledge of

ISO 13485

standards for medical device quality management systems. Understanding of FDA regulations relevant to medical device manufacturing. Mechanical knowledge related to device assembly, plastics injection molding, and electronic soldering. Experience working in a cleanroom environment with strict contamination controls. Familiarity with CGMP guidelines governing manufacturing practices for medical devices. Ability to interpret technical drawings, schematics, and work instructions clearly. Strong attention to detail with excellent manual dexterity and organizational skills. Effective communication skills for documenting processes and collaborating within teams. This position is an excellent opportunity for individuals committed to producing safe, reliable medical devices that meet the highest industry standards. We welcome applicants from diverse backgrounds who are eager to develop their skills within a dynamic manufacturing environment dedicated to excellence in healthcare technology.

Pay:

$23.00 - $25.00 per hour Application Question(s): Are you able to commute to San Carlos CA?

Work Location:

In person