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Job Title: Systems Engineer with (SaMD) Job Location: Somerset NJ 08873 (Remote) Onsite Requirements: Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Computer Science, or related field. 3-7 years of experience in systems engineering for medical devices, preferably SaMD. Strong understanding of medical device regulatory standards (IEC 62304, ISO 14971, ISO 13485, FDA QSR). Experience with requirements management tools (e.g., Jama, DOORS, Polarion). Experience with AI
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