Senior Staff Hardware Development Quality Engineer supporting Stryker’s Digital Health division. Leading design initiatives while ensuring compliance with regulatory standards in a hybrid work environment.
Responsibilities
Led advanced prototyping, testing, and research initiatives
Solved intricate design challenges independently
Designed and developed software systems
Authored and reviewed comprehensive project documentation
Applied deep understanding of clinical workflows and customer needs
Requirements
Bachelor’s degree in a science or engineering
Minimum of 6+ years of experience working in a highly regulated industry
Experience with software lifecycle processes (Agile SAFe/Waterfall)
Experience with software Failure Modes Effect Analysis (sFMEA)
Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601)
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