behaves in real-world use. You will operate within an ISO 13485-aligned Quality Management System (QMS) and an IEC 62304... and IEC 62304) Work within the ISO 13485-aligned QMS so device engineering supports design and development controls...
(Quality System) requirements, ISO 14971 (Risk Management) requirements, and IEC 62366 Medical Devices – Application...
of automotive functional safety standards (ISO 26262) and global electrification regulations (SAE, UL, IEC, GBT). Experience...
experience (IEC 61131-3) is a plus Ability to read and interpret technical drawings, schematics, and circuit diagrams...
such as FERC, NERC, NATF and OSHA, as well as industry standards such as ANSI, IEEE, EPRI, NEC, IEC. Familiarity with asset...
for engineering calculations Familiarity with design codes and standards such as NESC, EPRI Green Book, IEC, CSA, IEEE, ANSI, IBC...
, IEC, IEEE) Desired Qualifications: Master's degree in Electrical Engineering Professional Engineer (PE) license...
with one or more: MDR (Medical Device Regulation) ISO 14971 (risk management) IEC 62304 ISO 13485 or QMS environments SaMD security...
Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6). Interface with the core team and support...
or equivalent ISO/IEC 27001, ISO 42001 (AI Management) experience Microsoft, AWS, or Google AI/ML security training Completion...