Medical Device Assembler
San Jose, CA US
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 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.
- 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.
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.