Team Lead Validation Engineer

1 week ago


San Jose, United States KASTECH Software Solutions Group Full time
Job DescriptionJob Description

Title: Team Lead Validation Engineer

Experience: 8 - 10 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:

  • 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.
  • 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 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.


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