Medical Device Engineer III (DHF, design history files)

100% ONSITE NORTH CHICAGO ILPAY: $57-$62/hr

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REQUIRED:Experince managing DHF/design changes for existing medical devices and can perform hands-on verification testing. Supplier change experience is a plusDHF / Design Controls: Strong hands-on DHF experience, particularly managing changes to existing, on-market medical devices. This is the biggest priority.Medical Device Experience: Experience supporting Class I–III devices, including product lifecycle changes.Lab Testing: Must be comfortable writing verification protocols, executing physical testing, and documenting results.Regulatory Knowledge: Familiarity with ISO 13485, EU MDR, and applicable design control requirements.Education / Experience: Bachelor's degree required, along with several years of relevant industry experience. No recent graduates.Nice-to-HavesSupplier change experience is preferred, but not required.Combination product experience.Quality engineering background with strong technical/design control knowledge.Advanced degree (master's or PhD). PhD candidates are not considered overqualified.Experience in large medical device or pharmaceutical organizations.
JOB DESCRIPTION:This position supports on-market Class I–III medical devices, with a heavy focus on DHF, design changes, and hands-on laboratory testing. The manager needs someone experienced who can get up to speed quickly and work independently within approximately one month. xzbcwsv The role is roughly 60% lab testing and 40% documentation/protocol writing, depending on the project.