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.

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.