is responsible for leading R&D efforts for all medical fiber products, with a strong emphasis on innovation, reliability... and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825...
teams including R&D, Regulatory, and Manufacturing. Review and approve design documentation including Design History Files.... Familiarity with risk management standards (ISO 14971) and usability engineering (IEC 62366). Good Knowledge of Medical Devices...
product security, such as NIST, IEC 60601-4-5, IEC 81001-5-1, and others. Vendor Assessment - Evaluate third-party vendors... to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every...
between customers / market and the global digital and R&D organization. Displaying deeper knowledge of solution consulting approach... Industrial Networking, ISA/IEC 62443);MBA or coursework in digital transformation a plus. 10+ years’ experience in software...
quality standards for company products. Develop, modify, and execute software test plans according to IEEE 829/IEC 29119... and modification of software. Analyze test results to ensure existing functionality and recommend corrective action. Consult with R...
13485, and other relevant regulatory standards. Collaborate with cross-functional teams including R&D, Regulatory... standards (ISO 14971) and usability engineering (IEC 62366). Good Knowledge of Medical Devices & QMS (ISO 13485, 21 CFR Part...
Solutions is seeking a Staff Systems Engineer to join our R&D Instrument Systems team. This position is located in San Diego... including IEC 60601, ISO 14971, ISO 13485 and 62366 Display a solid understanding of theories/practices utilized...
of medical device R&D, product development, and clinical/regulatory procedures;including identifying use conditions, developing... Matter Expert Comprehensive knowledge of medical device standards and regulations (e.g., IEC 60601, IEC 62304, ISO 14971...
improvements in software and on hardware systems Develop R&D tools for data analysis and visualization Lead architecture... documentation, and unit/system verification in accordance with IEC 62304 and FDA requirements Support the transfer of designs...
. KLA focuses more than average on innovation and we invest 15% of sales back into R&D. Our expert teams of physicists... with applicable standards (NEC, NFPA 79, IPC, SEMI, IEC). Program PLCs (e.g., Siemens, Allen Bradley) and integrate control...