and IEC 62304. Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards...
engineering degree, knowledge of medical device standards and regulations (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC... 62366, IEC 81001-5-1), and experience supporting regulatory submissions such as 510(k), De Novo, PMA, or EU MDR. Baxter...
, conduct security risk assessments, and identify mitigation strategies in accordance with IEC 81001-5-1, ISO 14971, and FDA... of Standards and Technology (NIST), IEC 60601-4-5, and IEC 81001-5-1, and support security documentation efforts for global...
applying industry frameworks such as OWASP SAMM, BSIMM, NIST SSDF, NIST CSF, NIST AI RMF, ISO 27001, ISO/IEC 42001, IEC 62443...
risk frameworks (e.g., NIST AI RMF, ISO/IEC 42001) and AI governance practices. Working knowledge of MLOps/LLMOps concepts...
. Job Description: IEC, Range & Test Solutions (RTS) supports missile flight tests key to our nation's defense. RTS designs, develops, tests...
working with any standard system engineering process including MIL-STD-499, EIA-632, IEEE 1220 or IEEE/ISO/IEC 15288...
practices with regulatory and compliance requirements (EU CRA, NIST, ISO 27001, IEC 62443 or similar frameworks) Experience...
, including applicable design controls, IEC 62304 principles, cybersecurity considerations, and regulatory development processes...
with the Functional Safety Lifecycle (e.g., IEC 61511 / ISA 84) to achieve required risk reduction while maintaining high... with applicable standards and good engineering practice (IEC 61511/ISA 84, IEC 61508 concepts, IEC 62443 where applicable, NFPA/NEC...