Team Lead Validation Engineer
1 week ago
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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