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Medical Device Assembler

San Jose, CA

Posted: 01/09/2023 Position Categories: Manufacturing: Assembly Pay Rate: 22-28

Job Description

A biotech company is seeking mutiple Medical Device Assemblers to join their team!

SUMMARY: Responsible for the accurate and compliant manufacture of catheters used to remove blood clots from the brain by using a variety of semi-automated and automated equipment and processes.


  • Operate manufacturing and packaging equipment under company SOP and GMP guidelines in a Cleanroom Environment. Must be comfortable gowning up and wearing latex gloves.
  • Will be building catheter’s using small hand tools under a microscope to cut, crimp, slice, and clean small tubing and components.
  • Excellent communication skills Must be able to follow MPIs and Wis to ensure products are manufactured in accordance with product plans, quality, and regulatory.
  • Understand and perform manufacturing processes using Manufacturing Process Instructions (MP I’s)
  • Record data accurately on lot history records (LHR’s) in collaboration with manufacturing, quality, and R&D.
  • Accurately use computerized operating systems to run and monitor manufacturing equipment as required.
  • Monitor and record critical process parameters and ensure that proper documentation and GDP guidelines are followed.
  • Provide feedback to assist in the development of new processes or test procedures.
  • Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
  • Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.

Job Requirements


  • HS diploma and a minimum of 2-4 years of related experience in the medical device industry, including at least 2 years of direct manufacturing experience.
  • Should possess strong math skills.
  • Familiar with GMP, GDP procedures and requirements.
  • Ability to work independently or in team setting required.
  • Working knowledge of manufacturing equipment (i.e. hot boxes, adhesives, soldering, bonding, fuse joining) under microscope
  • Familiarity with testing: tensile, simulated use testing, or tests related to assigned projects.
  • Computer skills, including knowledge of Microsoft office products. Must be familiar and comfortable using a Laptop. Each operator is provided their own Laptop for documentation.

Additional Information

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.


Richmar is an Equal Opportunity Employer.

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