Validationn EngineerSparktek • San Francisco, CA, United States
Validationn Engineer
Sparktek • San Francisco, CA, United States
30+ days ago
Job type
- Full-time
Job descriptionProcess and equipment qualification (IQ / OQ / PQ). Development of test methods for Design 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 of new test methods and editing / redlining of old test methods Experience working in a regulated or medical device environment To define equipment requirements To draft equipment specifications To work on change management and releasing engineering change orders To design process validations and identify critical process parameters related to equipment Working
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 :
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Engineer • San Francisco, CA, United States
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