Medical Device Engineer

Medical Device Engineers are highly specialized professionals who use their skills to develop and modify medical devices. They develop, evaluate, monitor and maintain the performance of standard or customized medical equipment used in healthcare settings. Medical Device Engineers often act as expert witnesses in litigation matters that involve medical device design or manufacturing flaws, incidents of malfunctions or defects in the manufacture process and patient injuries resulting from the use of these devices.

Medical Device Engineer expert witnesses have a deep understanding of current technological advancements, device regulations per governing body standards such as FDA guidelines related to the development and manufacturing of approved medical equipment. With their expertise in engineering sciences they advise legal teams on relevant topics pertaining to cases involving defective medical products liability. Additionally, they may investigate incident reports by analyzing documents related to product maintenance protocols or post-market surveillance data which may be used as evidence during litigation proceedings.

Moreover, Medical Device Engineer experts testify before court with technical explanations on topics such as machine characteristics/functionality; failure analysis; pre-manufacturing product testing; standards development and quality control metrics for post-market products usage evaluations that meet safety requirements for healthcare organizations operations based on specific clinical needs prior to marketing approval processes at national/international levels with compliance that passes regulatory approvals by government agencies sanctions if necessary.

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