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Lead Validation Engineer

2 months ago

Sunnyvale, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The experience I am looking for is as follows.
  • 6 years relevant experience in medical device manufacturing.
  • Clean room environment experience.
  • Experience with Test Method Validation and/or 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.
  • bility to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
  • bility to work to a deadline and to handle multiple tasks simultaneously.
  • Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint.
  • Experience with 3D CAD Software SolidWorks.
  • Experience working with Engineering change management software & releasing engineering change orders.
Requirements:
  • 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.
  • uthoring/releasing of new test methods and editing/redlining of old test methods.
  • Experience working in a regulated and/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.
  • Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.