Senior Manager leading systems engineering for complex Point-of-Care diagnostic instruments, overseeing hardware, software, consumable, and assay integration. Responsible for system architecture, cross-functional integration with external partners, regulatory compliance (ISO 13485, IEC 62366, IEC 60601, ISO 14971), and risk analysis.… Will mentor junior engineers, drive technical decision-making across R&D, Quality, Manufacturing, and Regulatory teams, and manage the full product lifecycle from concept through commercial launch in a regulated environment.
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