Orange County Metro Area, CA
This Engineer will be responsible for supporting improvement projects for opto-mechanical and electro-mechanical systems and devices.
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.
5-8 years of professional experience.
Hands on process development including:
1) Fixture design,
2) Fixture development,
3) Fixture assembly,
4) Fixture IQ, OQ, PQ, and PV.
Manufacturing procedure development, manufacturing test procedures, engineering changes (ECN), process optimization experience.
Follow and execute corporate procedures including build to quarentine, rework jobs, expedite material from stores to the floor, first time buy, supplier approvals, protocols, test reports, and inspection method development.
Thorough knowledge and experience with engineering drawings, specifications and requirements.
Experience with PROe a plus.
Working knowledge and experience with ISO 13485 and transfer of Medical Devices from R&D to Manufacturing.
Must speak and read English.
Must be willing to create, build, test, evaluate, verify, validate, release and drive to successful conclusion processes for manufacturing including all necessary documentation.
Must be able to work in a team environment and accept expediter role to complete the project/task.
Resume must demonstrate a successful career in process development and release.
Bachelor's Degree Required