Manufacturing Associate III

As a Manufacturing Associate III, you will be responsible for assembling high-quality medical devices in a cleanroom environment while adhering to strict regulatory standards. This role requires strong attention to detail, experience with small component assembly, and the ability to perform quality checks throughout the production process. You will collaborate closely with supervisors, engineers, and quality teams to ensure the production of reliable, safe medical devices while maintaining a strong focus on continuous improvement.

Title: Manufacturing Associate III – Medical Device Assembly

Compensation: $25.00 - $30.00 per hour

Location: Milpitas, CA

Shift: Monday – Friday, 6:00 AM – 2:30 PM

Responsibilities:

• Assemble catheters and other medical devices using small hand tools, adhesives, calibrated instruments, and microscopes.
• Perform in-process quality checks and identify or report any quality or process issues immediately.
• Read and interpret engineering drawings, specifications, and manufacturing work instructions.
• Execute bonding processes including UV, Loctite, thermo-bonding (hot boxes, vertical shrinkers), and mechanical bonding as required.
• Operate within cleanroom standards, ensuring proper gowning and adherence to cleanroom protocols.
• Maintain compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA regulations.
• Assist supervisors, engineers, and technicians in resolving production line issues and identifying process improvements.
• Accurately document work performed and maintain production records and documentation.
• Demonstrate critical thinking skills to troubleshoot and resolve assembly issues effectively.
• Manage time efficiently to meet production deadlines in a fast-paced manufacturing environment.
• Train and mentor junior team members and support cross-training efforts as needed.
• Follow all safety protocols and handle tools, equipment, and materials safely.
• Be mechanically inclined to perform basic equipment setups and adjustments as needed.
  
  

Qualifications:

• High School Diploma or equivalent required.
• Minimum of 3-5 years of manufacturing or assembly experience, preferably in the medical device, electronics, semiconductor, or diagnostic industries.
• Experience working in a cleanroom environment is required.
• Strong understanding of GMP, ISO, FDA, and other regulatory compliance requirements.
• Demonstrated ability to work under a microscope for extended periods (up to 8 hours).
• Previous experience handling small components and adhesives with precision.
• Ability to read, interpret, and follow technical documents and standard operating procedures (SOPs).
• Familiarity with bonding techniques such as UV, Loctite, thermo-bonding, and mechanical bonding.
• Excellent communication skills with the ability to collaborate effectively across teams.
• Strong critical thinking and problem-solving abilities to support continuous improvement initiatives.
• Proficient in basic computer skills and comfortable using tablets or iPads for training and production documentation.
• Flexible and willing to work overtime as needed.
• Able to maintain accurate records and documentation in compliance with quality standards.