Where Have All the Systems Engineers Gone: Overview, History and Myths

By Christopher Miles
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Over the past few years, systems engineers and the role of systems engineering have all but disappeared from the medical device industry landscape. The impact on many organizations has been significant – slipped schedules, cost overruns, difficulty in component integration, limited focus on effective system risk management, numerous verification cycles due to late defect detection, and system designs that are evolutionary rather than planned.

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