Sr. Development Engineer I
, IEC 62366-1, ISO/IEC 27001, BS EN 62304. Familiarity with drug-device combination products and software as a medical...
, IEC 62366-1, ISO/IEC 27001, BS EN 62304. Familiarity with drug-device combination products and software as a medical...
. Understanding of medical device regulations and standards (e.g. ISO 13485, IEC 62304, ISO 14971, EU MDR) will be a huge...
regulations, and implement frameworks (e.g., COBIT, ITIL, ISO/IEC 38500) to optimize value delivery, mitigate IT risks.... Framework Mastery: Demonstrated expertise in COBIT, ITIL 4, ISO/IEC 38500, and ISO/IEC 27001. Technical Breadth: Strong...
and technical transfer OOS investigations and troubleshooting GMP/GLP laboratory experience ISO 9001, ISO/IEC 17025, or ISO...
, or relevant OT security certifications (e.g., ISA/IEC 62443). Deep understanding of cybersecurity fundamentals such as networking... Protocols such as DNP3, Modbus, IEC 104, OPC UA, including packet analysis and understanding protocol vulnerabilities...
electronics Experience with industry standards such as IEC, ISO, and automotive-specific requirements Additional Information...
· Working understanding of FDA, GMP, and ISO 13485 · Working understanding of the following standards: ISO14971, IEC 60601..., IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155 · Systems or clinical engineering experience · Experience with basic...
, NEMA, UL/IEC, ASHRAE, Uptime/TIA standards, protocols, and practices Preferred Qualifications: Selected candidate...
instrumentation. Knowledge of ISO/IEC 17025, FDA Quality System Regulations, GMP, GLP, and GxP requirements. Experience...
and communication systems. Applicable network and communication protocols: DNP, Modbus, SEL Communication Protocol, Goose Messaging, IEC...