Ideal candidate will be someone that is compiling the Compliance Checklist and creating the Risk Management Files – not someone that just performs System Verification where they are merely taking the OUTPUT. This candidate will be performing the analysis and creating the risk files, creating the checklist, showing the evidence, running the tests, investigating the issues, etc. Needs to really take charge on developing and leading the team on Verification Procedure, rather than just following the guidelines and taking the output.
Candidate will be tasked with helping write test protocols, execute test protocols and documenting this work with test reports as they go. Main functions of the tests are to perform Risk Management and Product Safety for these ophthalmic medical devices. Must be fluent in the main compliance standard IEC 60601-1 for electrical safety, risk management files, and extensive documentation to ensure the products are safe to release to manufacturing.
Client needs a System Engineer to support new product development. Fast-paced R&D environment and a very recently released product that they are updating with major features, essentially a 1.5 version of a pre-existing product. This engineer will be helping with tasks on the prior generation of the product and helping with sustaining and testing tool fixtures and modules, etc. Emphasis on Test Compliance as opposed to Quality Compliance – prior candidate was very strong but was used to a much more stringent Government-regulated environment, whereas this is product development and R&D with firm deadlines.
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