Sr. Connectivity Engineer
, and cybersecurity Understanding of Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA...
, 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...
to hazardous locations (NEC, CEC, ATEX, IECEx, etc.) Experience in product standards IEC 60079-0, -1, -2, -7, -11, -15, UL 508A...
., IEC, ISO) Proficiency in statistical analysis tools (e.g., Minitab, JMP) Excellent communication and technical writing...
. Work experience in an ISO/IEC 17025 accredited laboratory. Able to assist with basic troubleshooting, basic...
to plan, 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...
equipment. Specific experience with standards like UL 4600, ISO 26262, ISO 13849, ISO 25119, IEC 61508, or other industry...
experience with U.S., Canadian, and other international product safety standards, i.e., ANSI, CSA, UL, EN, IEC. Experience...
Cybersecurity certifications (CSSLP, OSCP, Security+, AZ-500, SC-100, GCSA...) Experience in SOC-2 / ISO 27001 / IEC-623433-4-X...
Cybersecurity certifications (CSSLP, OSCP, Security+, AZ-500, SC-100, GCSA...) Experience in SOC-2 / ISO 27001 / IEC-623433-4-X...