Primarily responsible for assembling complex medical devices for projects in Phase 3 (Design Verification). Assist Design and Development Engineers and Technicians in meeting quality specifications on Design and Development projects. Assist in transitioning Design and Development projects to production in a small team and collaborative environment.
· Efficiently, effectively, and consistently assemble and package complex medical devices
· Accurately and promptly fill out quality assurance records
· Conduct incoming, in process and final inspection of components, assemblies and finished goods
· Assist in inventory management
· Other duties as assigned
· High School diploma or Equivalent
· Ability to adapt quickly and positively to changing priorities and processes
· Ability to work under minimal supervision
· Ability to effectively use basic measurement tools including but not limited to rulers, calipers, micrometers, and pin gauges
· Experience with laser welding processes and techniques
· Experience with catheter processing equipment including hot boxes, laminators, split die bonders and tipping machines
· Experience working in a Controlled Environment Room (CER)
· Familiarity with ISO Quality Systems particularly in medical device development and manufacturing
· Ability to read, comprehend and perform processes documented in MPIs
· Ability to read and understand engineering drawings
· Ability to create job related records for quality purposes
· Standing and walking for short periods of time.
· Ability to use a microscope, including manipulating small object under a microscope for long periods of time.