Position : Validation Lead
Location : San Jose, CA (Onsite)
Long term contract role
Experience : 8+ years
Education : Bachelor of Science in Engineering, B.E. / B.Tech. Mechanical Eng. / M.S. Mech. Eng.
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 and / 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
The experience I am looking for is as follows :
- 6 years of 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, and PowerPoint.
- Experience with 3D CAD Software SolidWorks
- Experience working with Engineering change management software & releasing engineering change orders.
Silicon Validation Lead
Experience in pre-silicon Design Validation or emulation; leverage pre-silicon test cases for post-silicon validation. In this hybrid role, you will report to a Hardware Engineering Team Lead. Build and implement test plans for silicon bring-up, validation and characterization. Perform hands-on brin...
Lead Systems Validation Engineer
Hardware Engineering is looking for a system hardware validation engineer to develop new hardware test plans, test execution and validation of hardware designed for large scale deployment and integrated use. Your role extends to system-level validation, including workload simulation, low level valid...
Validation Lead
Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. To design process validations and identify critical process parameters related to equipment Working. Experience w...
SiliconOne Electrical Validation Lead.
You will deal with all chip validation aspects: Building validation plan, Coding the validation SW environment using Python and device SDK, test execution and results analysis. In this role, you will be responsible for Cisco SiliconOne Switch ASIC Post-Silicon Electrical Validation. Bachelor's or a ...
Validation Lead
Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. To design process validations and identify critical process parameters related to equipment Working. Experience w...
Senior Staff Hardware Validation Lead
We’re looking for a Hardware Validation Lead to help with verifying and validating our next generation electrical compute and sensor systems. Engineering Validation of the kit from component level all the way through integration in a vehicle, including architecting, designing and execution of design...
Lead Validation Engineer
Experience with Test Method Validation and/or Measurement System Analysis is preferred. Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. To design process validat...
Lead Validation Engineer
Experience with Test Method Validation and/or Measurement System Analysis is preferred. Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. To design process validat...
Team Lead Validation Engineer :: San Jose, CA :: Onsite
Title: Team Lead Validation Engineer. Experience with Test Method Validation and/or Measurement System Analysis is preferred. Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and ot...
Validation Lead
Development of test methods for Design V&V, Process Validation, and Production. Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work. To design process validations and identify critical process parameters related to equipment Working. Experience w...