Orange County Metro Area, CA
This Engineer will be responsible for supporting improvement projects for opto-mechanical and electro-mechanical systems and devices. Duties include - support for technical transfer of new products and technologies, process/product improvement projects, creation and release of manufacturing and test documentation. The Engineer will also be responsible for writing validation/verification protocols and reports, as well as documenting and developing manufacturing processes and equipment.
|Skills:||Thorough knowledge and experience with engineering drawings, specifications and requirements. Experience developing manufacturing processes and equipment and creating validation protocols for IQ/OQ/PQ and PV, as well as writing reports for medical devices. Experience with PROe a plus. Working knowledge and experience with ISO 13485 and transfer of Medical Devices from R&D to Manufacturing.|
Ability to manage and track own projects to required skills. Nice to have Solidworks or ProE experience
|Education:||B.S. Mechanical/Optical/Electrical/Biomedical Engineering or relative Operations/Manufacturing Engineering experience in Medical Device environment and product transfers|
Minimum 4 years experience with transfers in engineering role in Medical device field