What are the responsibilities and job description for the Validationn Engineer position at Sparktek?
Title : Validation Engineer
Experience : 4 - 5 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 :
- 3 years relevant experience in Medical Device Manufacturing.
- Clean room environment experience
- Experience with Test Method Validation and 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.
- Experience with Microsoft Office including Microsoft Word, Excel, and PowerPoint.
- Experience with 3D CAD Software SolidWorks
- Experience working with Engineering change management software & releasing engineering change orders.
Job duties :