processes in compliance with current FDA guidance and IEC 62304 . Work closely with Clinical Engineering and Product Management.... Strong understanding of software development and testing for medical devices , including required documentation and standards (e.g., IEC...
, and teams. Other: Certifications: CISA, CISM, CISSP, IEC/ISA-62443 are desirable. Experience in identifying...
techniques. Proficiency in UL and IEC agency requirements and approval procedures for drives. Expertise in utility interaction...
of assigned product family to help ensure product compliance to applicable regulatory standards (e.g. UL, IEC, ANSI) Creates... specifications and standard requirements (UL, CSA, NOM, CCC and IEC) Supports the creation and execution of verification...
knowledge of IEC 60601-1 3 rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral... evaluation using IEC generated test reports forms Communicate with internal/external labs, technicians, and design engineers...
recommendations to product teams Authoring Human Factors artifacts required for regulatory compliance, including adherence to IEC... at least one successful FDA approval and IEC 60601-1-6 certification (IEC 62366 TRF). Location: Lake Forest, CA, or Fort Worth, TX (must be able...
. Experiences with medical devices including FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601, and other related external standards...
network design strategies and IT service delivery roles. Familiarity with ISO/IEC, CENELEC, and BICSI cabling standards...
of assigned product family to help ensure product compliance to applicable regulatory standards (e.g. UL, IEC, ANSI) Creates... specifications and standard requirements (UL, CSA, NOM, CCC and IEC) Supports the creation and execution of verification...
components in the North America and Latin America Region (incl. IEEE, IEC, ANSI, NEC, OSHA) Ability to focus on detailed work...