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R&D Engineer I, II, III - Medical Devices (Electrophysiology, Neurovascular, Coronary)
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De functie
Supports the end-to-end development lifecycle of vascular, neurovascular, and electrophysiology medical devices, including stents, catheters, and delivery systems, under FDA Design Controls and ISO 13485.
Contributes across Phase I through Phase IV development and provides sustaining R&D support for released products.
Design and modify components using SolidWorks; develop prototypes; and define verification and validation strategies with formal test protocols.
Execute design verification testing and validation, perform bench testing, dimensional inspections, and product performance evaluations.
Document test results and technical findings; develop, implement, and refine inspection methods; and assess measurement systems for accuracy and repeatability.
Collaborate with cross-functional teams (Quality, Operations, Manufacturing Engineering) and suppliers to investigate failures, drive improvements, and support packaging, labeling, and commercialization readiness.
Contributes across Phase I through Phase IV development and provides sustaining R&D support for released products.
Design and modify components using SolidWorks; develop prototypes; and define verification and validation strategies with formal test protocols.
Execute design verification testing and validation, perform bench testing, dimensional inspections, and product performance evaluations.
Document test results and technical findings; develop, implement, and refine inspection methods; and assess measurement systems for accuracy and repeatability.
Collaborate with cross-functional teams (Quality, Operations, Manufacturing Engineering) and suppliers to investigate failures, drive improvements, and support packaging, labeling, and commercialization readiness.
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