medical devices, 510(k) support, IEC 60601-1, EU MDR technical documentation, or customer-driven regulatory submissions... preferred. Familiarity with IEC 60601-1, IEC 62304, IEC 62366, ISO 14971, and electrical medical device requirements preferred...
-level considerations Contribute to electrical safety and compliance activities (e.g., IEC 60601), including risk... Qualifications Experience working with capital equipment or complex electromechanical medical devices Familiarity with IEC 60601...
cybersecurity standards (IEC 62443, NIST). Maintain comprehensive, current technical documentation — including architecture..., IEC 62443). How to Apply Would you like to know more about this opportunity? For immediate consideration, please send...
, including ISO 13485, ISO 14971, IEC 62304, and IEC 60601. Provide regular status updates and lead project reviews. Ability...
. We are willing to train. We are a member of the IEC and encourage training at all levels. Candidate Requirements: Willing...
, IEC, etc.). You have strong knowledge and are experienced with ownership, facilitation or execution of the CAPA process...
. Required 3 Years About Us: InterSources Inc , is a Small, Woman, and Minority-Owned Business Enterprise, ISO/IEC 27001, SOC 2...
in alignment with the IEC 62304 software development lifecycle, scaled to the product's software safety classification (Class A/B/C... compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls...
and cybersecurity considerations for networked subsystems (FDA cybersecurity guidance, IEC 81001-5-1). Experience supporting FDA or EMA...
(Modbus, DNP3, IEC 61850). Strong background in IP Networking, VLANs, and cyber security principles relevant to industrial...