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ME/Systems & Teset Method Validation Engineer / USA

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Added:2020-07-03
Location: California, USA
Salary:
Duration:Permanent
Apjid3

The Role:

Location: Menlo Park, CA

Overview:
1. At least a Bachelors' degree in an engineering discipline preferably mechanical engineering.
At least five years' experience working as an engineer in development or verification.
* At least five years' experience in the medical device field (or similar regulated industry)
* Thorough understand of the application of design controls in a regulated industry
* Experience writing test documentation such as Test Plans, scripts and test results reports
* Ability to analyze/interpret test results and provide recommendations to improve testing

Primary Skills:
* Review, understand, evaluate, and propose changes (additions or modifications) to system-level requirements and interface requirements (especially mechanical-based requirements) for the peritoneal dialysis system which includes the cycler machine and the associated disposables.
* Create verification or test plans as part of the test method to qualify design changes and thoroughly verify critical requirements
* Review, evaluate and modify verification protocols that test system-level requirements, interface requirements, and mechanical requirements.
* Author new verification protocols that test system-level requirements, interface requirements, and mechanical requirements.
* Conduct verification protocols and write engineering reports.
* Troubleshoot systemic issues (esp. mechanical issues) with dialysis systems using FMEA & Fishbone analysis.
* Conduct and Contribute to Design of Experiments geared to isolate and measure parametric influences.
* Collaborate with a team of engineers to develop tests and root-cause problems.
* Supports FMCNA's mission, vision, core values and customer service philosophy.
* Adheres to the FMCNA Compliance

Secondary Skills:
* Review, understand, evaluate, and propose changes (additions or modifications) to system-level requirements and interface requirements (especially mechanical-based requirements) for the peritoneal dialysis system which includes the cycler machine and the associated disposables.
* Create verification or test plans as part of the test method to qualify design changes and thoroughly verify critical requirements
* Review, evaluate and modify verification protocols that test system-level requirements, interface requirements, and mechanical requirements.
* Author new verification protocols that test system-level requirements, interface requirements, and mechanical requirements.
* Conduct verification protocols and write engineering reports.
* Troubleshoot systemic issues (esp. mechanical issues) with dialysis systems using FMEA & Fishbone analysis.
* Conduct and Contribute to Design of Experiments geared to isolate and measure parametric influences.
* Collaborate with a team of engineers to develop tests and root-cause problems.
* Supports FMCNA's mission, vision, core values and customer service philosophy.
* Adheres to the FMCNA Compliance

Educational Qualifications
B.S in Engineering


How to Apply









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