Directive EMC Directive Applicable IEC / EN standards CSA electrical safety standards Lead Design for Compliance... certification. Strong knowledge of UL, CSA, IEC, and EN electrical safety standards. Experience certifying industrial...
. Applies knowledge of IEC 62304 to product development and sustaining engineering projects. Engage with the development team...
13485 environment. Advanced knowledge of IEC 62304 (software standard). Proficiency with AI tools such as VS Code, GitHub... What Sets You Apart Experience with digital health SaMD applications and IEC 82304. Working knowledge of creating...
such as INCOSE guidance, ISO/IEC/IEEE 15288, or EARS Experience leading system integration, verification, validation, and testing...
and audit, and contribute to cybersecurity quality activities, applying IEC 62304 and strong technical writing and cross... affecting software medical devices such as IEC 62304, ISO 14971, 21 CFR 820.30 and EU MDR. Experience with creation...
, ensuring compliance with relevant safety standards (e.g., SEMI, IEC, UL, CE, ISO). Identify potential safety risks in product...). Familiarity with global safety standards, such as SEMI, NFPA, IEC, UL, CE, ISO, RoHS, and other relevant safety and compliance...
and guidance (e.g., IEC 62443, NIST SP 800-82) and applying them pragmatically in operating environments. Experience working...
ecosystem) and GPU-accelerated pipelines. Familiarity with functional safety standards (ISO 13849, ISO 25119, IEC 61508, ISO...
, and testable Derive cybersecurity requirements from FDA guidance and consensus standards (IEC 62443, IEC 81001-5-1, AAMI SW96... with system-level threat modeling methodologies (e.g., STRIDE, PASTA, or TARA as defined in IEC 81001-5-1 / AAMI SW96) Working...
, cable systems, and rotating machinery. Extensive familiarity with codes, standards, and regulatory requirements (IEEE, IEC...