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.
- 5+ years of professional experience.
- Relative Operations/Manufacturing Engineering experience in Medical Device environment and product transfers
- Hands on process development including: 1) Fixutre 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.
B.S. Mechanical/Optical/Electrical/Biomedical Engineering and/or Degree.