of information security, and IT jobs. Detailed knowledge of common information security management frameworks, such as ISO/IEC 27001...
strategies. Ensure compliance with relevant safety standards (e.g., ISO 13849, IEC 61508, UL3100, ANSI/RIA R15... and methodologies (e.g., ISO 13849, IEC 61508). 7+ years of experience with complex electromechanical systems Your preferred...
-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX...
and Summative), and Use Risk Management. Strong working knowledge of FDA and IEC regulatory expectations for Human Factors. Proven...
and Summative), and Use Risk Management. Strong working knowledge of FDA and IEC regulatory expectations for Human Factors. Proven...
understanding of relevant regulatory certifications and testing requirements (e.g., UL, CE, IEC) to ensure product compliance... and testing requirements (e.g., UL, CE, IEC) for battery systems, and experience certifying products to these standards Expertise...
Administrative Director, Laboratory Technical Specialists, the Immune Effector Cell Therapy (IEC) Quality RN and BMT Quality RN...
Administrative Director, Laboratory Technical Specialists, the Immune Effector Cell Therapy (IEC) Quality RN and BMT Quality RN...
packaging including PCBA mechanical design, incorporation of sensors and plastic PCBA enclosures that comply with IEC IP54...
(such as IEC 62366, FDA guidance, and ISO 14971) under the guidance of senior team members. Support HF validation testing... devices and combination products (e.g., IEC 62366 and FDA guidance) Experience applying usability engineering processes...
, combination products, and health IT (e.g., IEC 62366 and FDA guidance) Experience applying usability engineering processes...
system, transmission, distribution, and power line carrier logic, coordination studies, relay settings, IEC 61850...
Regulation (MDR), ISO13485, ISO 14971, and IEC 62034 preferred. 2 - 4 years working in a regulated industry (FDA and Software...
system, transmission, distribution, and power line carrier logic, coordination studies, relay settings, IEC 61850...
and validation plans Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDR design control requirements for medical...
of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37) Experience translating clinical workflows and business...
. Ensures the Labâs operations comply with all requirements of ISO/IEC 17025 and applicable Instron Quality Manuals. Defines...
with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601..., IEC 62353, and ISO 14971. ● Strong understanding of system design, electronics, mechanical and software integration...
with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601..., IEC 62353, and ISO 14971. ● Strong understanding of system design, electronics, mechanical and software integration...
Knowledge: Leverage a strong understanding of IEC 62304 and other relevant ISO standards to guide development. Clinical...-on experience with requirements management tools and V&V activities. Knowledge of IEC 62304, ISO standards, and regulatory...