, and debugging Knowledge of medical device regulations (21CFR Part 820, ISO13485) and electrical safety standards (IEC EN60601..., EN, IEC) WHAT WE OFFER: Join our team and discover a work environment that sparks innovation, collaboration, and growth...
, and/or project leadership. Provides technical guidance for EMC Compliance standards to less experienced engineers. (IEC 60601-1-2...
or electrical codes, and test methods under ASTM, CSA, UL, EN/IEC, NFPA, and other standards. Experience working with diverse teams...
, reports, and analysis that adheres to FDA Guidelines for usability, as well as IEC Standards 62366-1 and 60601-1-6. Maintain...
%, including internationally. Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 Prior medical device experience...
with industry-specific standards and regulations, such as UL, IEC 61131, is advantageous. Flexible working hours may be necessary...
with IEC 62304 for medical device software, and IEC 60601 family of standards Apply Now Learn more about our health...
and standards in the oil and gas industry, i.e., API, BS, ISO, ASME, ANSI, IEC, ISA, IEEE, etc. Strong analytical...
, and cybersecurity Understanding of Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA...
, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed... Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe: acc. to new...