Tech Transfer Engineer - Manufacturing
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.
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 to Manufacturing.
Ability to manage and track own projects to required skills. Nice to have Solidworks or ProE experience
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