Techniques Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles...
and IEC applications, including: conduit fittings and cable glands, industrial control and electrical apparatus, enclosures...
), regulatory compliance, and standards such as ISO 9001, ASME, and IEC. Proficiency in quality tools and methodologies (e.g., SPC...
with a regulated software development processes or familiarity with FDA and ISO standards like IEC 62304 is a plus. Experience...
. Regulatory Compliance: Ensures that all software components meet regulatory requirements, such as FDA guidelines, IEC..., in Kotlin and Swift. Knowledge of regulatory requirements, including FDA, IEC, and ISO standards. Familiarity with FDA...
preferred) Previous experience in cardiac electrophysiology and/or cardiac rhythm management Familiarity with IEC 62304... for medical device software, and IEC 60601 family of standards Apply Now Learn more about our health and wellness benefits...
with Pro Panel Autodesk Inventor SAP Microsoft Teams Industry standards (UL, NEC, CSA, IEC) PLCs, HMIs, and motor drives...
Understanding of, or experience with, regulatory requirements such as FedRAMP, GDPR, PCI DSS, HIPAA, SOC-2, ISO/IEC. What Makes...
preferred. Experience with ISO 26262 and IEC 61508 preferred. Ability to work efficiently in a fast-paced development...
using one of the IEC 61131 PLC Programming languages i.e. Ladder Logic, Function Block Diagram, Structured Text...