with Schneider DCS and M580 PLC systems, or equivalent. Knowledge of industry standards such as IEC 61449, IEC 61131, OPC-UA...
with industrial control system protocols (e.g., Modbus, IEC 61850, DNP3, OPC, BACnet) and/or network protocol analysis (e.g., Tcpdump...
with industrial control system protocols (e.g., Modbus, IEC 61850, DNP3, OPC, BACnet) and/or network protocol analysis (e.g., Tcpdump...
product development is highly desired, including knowledge of regulatory processes such as IEC 62304, safety considerations...
of relevant experience. Nice to Have Expert knowledge of Medical Product verification, IEC-62304 and FDA guidance in... of Medical Product verification, IEC-62304 and FDA guidance. Thorough understanding of creating test protocols for verifying...
, required Preferred Requirements & Qualifications: Supervisory experience Successful completion of auditor training, ISO/IEC 17025, ISO...
, required Preferred Requirements & Qualifications: Supervisory experience Successful completion of auditor training, ISO/IEC 17025, ISO...
. Proficient with SW fundamentals and IEC 62304 standard for medical device SW. Possess proactive attitude and be a self-starter...
to regulatory standards including IEC 60601-1, 60601-2, 60825-1, 60601-1-6, ANSI Z80.36, IEC 62471, ANSI/AAMI SW96..., 60825-1, IEC 62366, 60601-1-6 ANSI Z80.36, IEC 62471 and other relevant compliance and safety standards...
safety practices & compliance standards (IEC, NEC, UL, CSA) into the test plans and procedures and subsequent testing... of compliance standards to the designs (IEC, NEC, UL, CSA) Experience in design, build & deployment of text fixtures for electrical...
software development processes or familiarity with FDA and ISO standards like IEC 62304 is a plus Experience with low level...
installations Experience with application of compliance standards to the designs (IEC, UL, CSA, NEC etc.) Experience in problem...
with security standards/frameworks (IEC 62443, NIST 800-82, and other relevant standards) Helps promote a culture of cybersecurity... System (ICS) security principles and best practices (e.g., IEC 62443, NIST, NERC CIP) Working knowledge of SCADA/HMI systems...
applications within AWS Cloud preferred. Detailed understanding of IEC 62304, ISO 14971, FDA and MDR design control requirements...
across various subsystems within the AET products, as per ISO 14971, IEC 62304, & IEC 80002-1 Ensure the adequacy of software design... and prediction Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDD design control requirements for medical...
and internally. Execute electrical engineering compliant to medical device product safety regulations such as IEC 60601-1 and EMC... safety regulations such as IEC 61000-x-x. With guidance, and at all times following the Cogmedix Design Controls compliant...
. Strong knowledge of global medical device regulations, such as FDA, EU MDR, ISO 13485, ISO 14971, IEC 62304, DCB, and other relevant...
, particularly Ignition Proficiency with IEC 61131-3 languages, particularly Structured Text / SCL. Experience gathering..., BACnet, UDP, other communication protocols Familiarity with IEEE, IEC standards. Ability to occasionally lift up to 50 lbs...
Level 3 certification and ISO registrations including 9001:2015, 20000-1:2018, and ISO/IEC 27001:2013. SMS is headquartered...