Highlights
The candidate should have hands-on experience with IQ/OQ/TMV, test protocol development & execution, SolidWorks, Windchill, software validation, PFMEA, GD&T, DOE, process documentation, and project coordination. We are looking for a Senior Designer – Design Verification & Validation with experience in medical device/manufacturing engineering to support equipment and production fixture validation.
Numbers & Facts
| Location | Irvine, CA |
| Job Type | Contractor |
| Website | https://www.ktekresourcing.com |
Description
We are looking for a Senior Designer – Design Verification & Validation with experience in medical device/manufacturing engineering to support equipment and production fixture validation. The candidate should have hands-on experience with IQ/OQ/TMV, test protocol development & execution, SolidWorks, Windchill, software validation, PFMEA, GD&T, DOE, process documentation, and project coordination. Experience in design documentation, process characterization, manufacturing support, and engineering change management is required.
Job Responsibilities
Mandatory Skills
IQ/OQ/TMV (Equipment Validation)
Design Verification & Validation (DV&V)
Test Protocol Development & Execution
SolidWorks
Windchill PLM
Software Validation (CSV)
PFMEA
GD&T
DOE (Design of Experiments)
Process Instructions & Documentation
Manufacturing Engineering
Medical Device (Preferred)
Project Management
Skills
- Mechanical Design
- Windchill PLM Software
- SolidWorks