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...
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...
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...
all rack designs meet safety and certification requirements such as NEC/NFPA, IEEE, and UL/IEC. Design, review, or integrate...
compliance efforts related to standards and frameworks such as IEC 62443, ISO 27001, NIST, NERC CIP, and CTPAT What You Bring...