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Validationn Engineer

Sparktek
San Francisco, CA Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/4/2025

Title : Validation Engineer

Experience : 4 - 5 years

Location : San Jose, CA, USA

Education : Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.

The experience I am looking for is as follows :

  • 3 years relevant experience in Medical Device Manufacturing.
  • Clean room environment experience
  • Experience with Test Method Validation and Measurement System Analysis is preferred.
  • Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
  • Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
  • Strong organizational skills, detail-oriented.
  • Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint.
  • Experience with 3D CAD Software SolidWorks
  • Experience working with Engineering change management software & releasing engineering change orders.

Job duties :

  • Process and equipment qualification (IQ / OQ / PQ).
  • Development of test methods for Design V&V, Process Validation, and Production
  • Validation of test methods
  • Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
  • Authoring / releasing of new test methods and editing / redlining of old test methods
  • Experience working in a regulated or medical device environment
  • To define equipment requirements
  • To draft equipment specifications
  • To work on change management and releasing engineering change orders
  • To design process validations and identify critical process parameters related to equipment Working
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