Primarily responsible for assembling complex medical devices for projects in Phase 2/3 (Design Verification). Assist Design and Development Engineers and Technicians in demonstrating process feasibility and 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 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 process development of complex medical devices
- Assist in inventory management
- 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.
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Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.