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Senior Designer - Design Verification and Validation

KTEK RESOURCING

  • Irvine, CA
  • 30+ days ago
  • Contractor
KTEK RESOURCING
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Skills

  • Design Verificationunmatched
  • Documentationunmatched
  • Engineering Change Managementunmatched
  • Geometric Dimensioning and Tolerancingunmatched
  • Manufacturing Engineeringunmatched
  • Medical Equipmentunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Manufacturingunmatched
  • Process Validationunmatched
  • Production Supportunmatched
  • Project/Program Coordinationunmatched
  • Software Validationunmatched
  • SolidWorksunmatched
  • Test Plan/Scheduleunmatched
  • United States Department of Energy (DOE)unmatched
  • Validation Testingunmatched
  • Windchill PLM Softwareunmatched

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

Numbers & Facts

LocationIrvine, CA
Job TypeContractor
Websitehttps://www.ktekresourcing.com

Skills

  • Mechanical Design
  • SolidWorks
  • Windchill PLM Software

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