device regulatory environment and standards (for example, IEC 60601-1IEC 60601-1 and applicable FDA guidance). Experience...
. Assist in security risk management activities following ISO 14971, IEC 62304, and FDA cybersecurity guidance. Support... apply! Familiarity with FDA cybersecurity guidance, ISO 14971, IEC 62304, and AAMI TIR57/TIR97/SW96. 5 years of software development...
Communicates status frequently Performs job functions in accordance with applicable standards, such as GMP, IEC and ISO standards...
compliance with applicable regulatory standards (e.g., IEC 60601). Develop detailed specifications, schematics, and PCB layouts...
with FDA, ISO 13485, IEC 60601, or other relevant medical device standards. Experience with low-power design and miniaturized...
. Understanding of SCADA controls architecture and communication protocols (Modbus, DNP3, IEC 61850) Must bring design experience...
knowledge and understanding of security regulations and best practices such as SOX, HIPAA, CIS, ISO/IEC 42001, EU AI Act...
in regulatory compliance or product safety for medical devices. Deep knowledge of IEC 60601 and IEC 61010 standards, IVDR, MDR...
network architecture (ISA-95/IEC 62443), DMZ segmentation, identity management, and secure data exchange. Led and managed...
. Experience working with and testing electrical and mechanical systems. Experience with DO-178, IEC 61508, or similar...