Validationn Engineer
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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:
Process 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
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:
Process 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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