Senior Design Quality Engineer, Digital Orthopedics
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA's General Principles...
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA's General Principles...
regulations and standards (e.g., ISO 13485, IEC 62304). Perform software debugging, testing, and validation to ensure high... with medical device regulations and standards (e.g., ISO 13485, IEC 62304). Experience with software debugging, testing...
with UL, CSA, IEC Regulations and standards - Present products to prospective clients;- Cross-sell and up-sell...
in a plant/manufacturing environment Knowledge of industrial control systems security standards (e.g., IEC 62443) Able to work...
of medical device regulations and standards, including IEC 62304, ISO 13485 and FDA 21 CFR Part 820. Proven in-depth knowledge...
or certifying agencies (UL, NSF, IEC, etc.) is a plus. Basic understanding of Intellectual Property law (especially patents/claims...
ISA and IEC control system standards. PREFERRED SYSTEM CAPABILITIES AND SKILLS Proficient in Allen Bradley PLC family...
components for testing and qualification. Familiarity with UL, CSA, FM, IEC and FCC a plus. Excellent written and verbal...
system, transmission, distribution, and power line carrier logic, coordination studies, relay settings, IEC 61850...
Understanding of, or experience with, regulatory requirements such as FedRAMP, GDPR, PCI DSS, HIPAA, SOC-2, ISO/IEC. What Makes...