POSITION SUMMARY

We are looking for a reliable and detail-oriented Manufacturing Associate with demonstrated experience working in a manufacturing production line setting in a controlled clean room environment. The ideal candidate thrives on the production line, excels in collaboration, and is eager to contribute to a dynamic, cutting-edge high-tech startup.

QUALIFICATIONS

· 2+ year’s experience in industries like medical device manufacturing, pharmaceuticals, biotechnology, or semiconductor production.
· Understanding of cleanroom standards (ISO Class 5-8 or equivalent) and contamination control practices.
· Familiarity with GMP, ISO 13485, or FDA regulations.
· Knowledge of basic inspection tools (calipers, microscopes, etc.).
· Prior experience operating and setting up injection molding machines is a plus.
· High school diploma or equivalent; additional vocational and technical training is required.
· 2 years of experience working in a cleanroom, manufacturing, or laboratory environment.
· Strong attention to detail and manual dexterity.
· Ability to follow detailed instructions and work under minimal supervision.
· Ability to read and interpret technical drawings, schematics, and work instructions.
· Good manual dexterity and attention to detail.
· Comfortable working in full cleanroom attire (gown, gloves, mask, shoe covers, etc.).
· Strong communication skills and team-oriented attitude.
· Basic computer skills for data entry and documentation.
· Ability to lift up to 50 lbs and work in a standing position for extended periods.
· Willingness to work flexible hours, including overtime or weekends as needed.
· 20 min response time to San Rafael facility near Andersen Dr and Bellam Blvd.

WORKING CONDITIONS

· Extended periods standing or sitting.
· Repetitive hand motions.
· Controlled environment with temperature and particle specifications.
· Occasionally lift heavy items up to 50 lbs.
Note: This job description is not designed to cover or contain a comprehensive list of activities, duties, or responsibilities that are required of the role or employee. They may change, or new ones may be assigned at any time with or without notice.

· Configure and operate injection molding machines according to production schedules and Work Instructions.
· Perform mold changes, machine adjustments, and minor repairs as needed.
· Monitor production runs to ensure parts meet quality standards and specifications.
· Assemble, inspect, test and package products in a cleanroom environment per established Work Instructions (WI).
· Prepare and operate packaging machines according to production schedules and Work Instructions.
· Maintain cleanroom protocols to minimize contamination risks.
· Monitor environmental conditions and report any deviations or concerns.
· Operate and maintain cleanroom equipment such as laminar flow hoods, microscopes, or other specialized tools.
· Perform routine cleaning and sanitization of work areas, equipment, clean room and surfaces.
· Document production activities accurately and completely, ensuring compliance with Work Instructions, Standard Operating Procedures, GMP, ISO, or other regulatory standards.
· Follow strict handling and labeling requirements for sterile or sensitive materials.
· Inspect parts and finished products for defects, nonconformances, or inconsistencies.
· Collaborate with quality assurance, engineering, and other teams to resolve process or product abnormalities.
· Participate in cleanroom audits, inspections, and continuous improvement activities.
· Handle chemicals per Work Instructions
· Move and batch raw materials and finished goods
· Perform any other tasks in the manufacturing facility as required and reasonable