and practices, resulting in CMMI Level 3 certification and ISO registrations including 9001:2015, 20000-1:2018, and ISO/IEC 27001...
safety verification per IEC 60601-1 and associated particular and collateral standards. Perform basic safety tests... compliance against IEC 60601-1 (General Standard), including applicable particular (60601-2-x) and collateral standards (60601-1...
, ISO 14971, IEC 62304, 21 CFR parts 210, 211, 803, 820, or other quality system regulations Excellent written and verbal...
, including 21 CFR Part 820, ISO standards, and IEC standards or other safety critical industries (highly preferred) Knowledge...
Systems Engineering Body of Knowledge, and ISO/IEC/IEEE 15288 Comprehensive mastery of requirements engineering, traceability...
and repair electrical circuits, control wiring, and communication networks. Work with DNP3, Modbus, and IEC 61850 SCADA...
like NIST, ISO 27001, IEC 62443 for industrial cybersecurity, and partner with GRC to maintain policies, standard operating... Understanding of regulatory and safety standards applicable to manufacturing and retail such as OSHA, NIST SP 800-82, ISO/IEC 27019...
experience, including translation/localization vendors Knowledge / Skills / Abilities Familiarity with ISO/IEC 82079-1...
. Experience with vision systems, robotics, and connected medical platforms strongly preferred. Experience with IEC 60601 series...
Experience with machine safety systems (STO, SS1, SLS) and relevant standards (IEC 62443, ISO 13849) Mindset & Attributes...