Systems Engineer

Must have a Bachelor’s degree in Engineering or a related field plus a minimum of 5 years of post-baccalaureate experience in the job offered or related role in the Medical Device industry. Of the required experience, candidates must have 4 years of experience working with healthcare professionals to turn user requirements into technical requirements, writing and managing system requirements for a Medical Device, authoring verification and validation test plans and protocols and executing tests, authoring and/or participating in design reviews, design FMEAs, and documentation for regulatory submissions, performing user needs -> requirements -> design outputs -> validation/verification trace activities, designing/managing usability studies.