experience designing, developing, and validating safety critical systems per ISO26262 or other relevant safety standards (IEC...
designing, developing, and validating safety critical systems per ISO26262 or other relevant safety standards (IEC 61508...
safety and quality. You are experienced with relevant medical device industry standards (ISO 14971, IEC 62304, IEC 62366, FDA...
, and/or IEC-62304). Demonstrated understanding of the Clinical Lab environment. Enterprise class information technology...
, and/or IEC-62304). Demonstrated understanding of the Clinical Lab environment. Enterprise class information technology...
of a work product in Technical Process Areas associated with the ISO/IEC 15288. Perform systems engineering activities.../IEC 15288 processes. Assist in performing systems engineering activities in the ISO/IEC 15288 Agreement or Enterprise...
of a work product in Technical Process Areas associated with the ISO/IEC 15288. Perform systems engineering activities.../IEC 15288 processes. Assist in performing systems engineering activities in the ISO/IEC 15288 Agreement or Enterprise...
subject to IEC 62304 software development life cycle processes and other global regulatory standards. Experience in...
and integration testing, and cybersecurity Understand Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part...
requirements, and design specifications. Excellent written and verbal communication skills. Experience with IEC 60601-1, IEC... 60601-1-2, IEC 61326-1, IEC 61326-2-6, EU Radio Equipment Directive (RED), EN 300 330, EN 300 328, FCC Title 47 Part 15...