Team Lead Validation Engineer

Title: Team Lead Validation EngineerExperience: 8 - 10 yearsLocation: San Jose, CA, USAEducation: Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Engg. / M.S. Mech. Engg.The Experience I Am Looking For Is As Follows6 years relevant experience in medical device manufacturing. Clean room environment experienceExperience 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 SolidWorksExperience working with Engineering change management software & releasing engineering change orders.