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Lead Validation Engineer

2 months ago

San Jose, United States VeeRteq Solutions Inc. Full time
Job DescriptionJob Description

Job Title: Lead Validation Engineer
Experience: 8 - 10 years
Location: San Jose, CA, USA
Education: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engineering, M.S. Mechanical Engineering

Experience Requirements:

  • Minimum 6 years of relevant experience in medical device manufacturing.
  • Experience working in a clean room environment.
  • Experience with Test Method Validation and/or Measurement System Analysis is preferred.
  • Knowledge of computer software for data analysis, 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 and detail-oriented.
  • Ability to collaborate within an organization across all functional departments (e.g., Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.).
  • Ability to work to a deadline and handle multiple tasks simultaneously.
  • Proficiency in Microsoft Office, including Microsoft Word, Excel, and PowerPoint.
  • Experience with 3D CAD Software SolidWorks.
  • Experience working with Engineering change management software and releasing engineering change orders.

Job Duties:

  • Process and equipment qualification (IQ/OQ/PQ).
  • Development of test methods for Design Verification & Validation (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 new test methods and editing/redlining old test methods.
  • Experience working in a regulated and/or medical device environment.
  • Defining equipment requirements.
  • Drafting equipment specifications.
  • Working on change management and releasing engineering change orders.
  • Designing process validations and identifying critical process parameters related to equipment.