project follow-up. This role supports Category, IEC, Engineering, Supply Chain, Finance, Procurement Enablement, and site... verification, RFQ support, and sourcing project inputs. Coordinate with Category, IEC, Engineering, Quality, Finance, and Supply...
device’s IEC 60601-1-2 compliance. Specifications & Drawings: Develop detailed manufacturing specifications & Instructions... or industry/education Required What else we look for (Preferred): Strong working knowledge of IEC 60601-1 and IEC 60601-2...
and apply medical device standards, including IEC 60601 and ISO 14971, to product development activities. Collaborate with cross... and software components. Strong knowledge of Medical Device Standards (ISO 14971, IEC 60601 Series), Risk Management, FMEA...
, etc.). Background and understanding of MDR regulations and best practices for medical device human factors (e.g., IEC 62366, AAMI HE75...
ISO 14971 & IEC 60601 Standards FMEA & Risk Management Requirements Management & Traceability Verification & Validation... experience. Medical Device Development background. FMEA, Risk Management & V&V experience. ISO 14971 & IEC 60601 knowledge...
. Ensure the hardware design adheres to relevant safety standards, such as ISO 26262 or IEC 62133, and conduct safety analysis...
zoning/segmentation, remote access, and controls/OT cybersecurity concepts such as ISA/IEC 62443). Experience...
, with a strong emphasis on ISA/IEC 62443, supported by NIST CSF 2.0 and ISO 27001. Bachelor’s degree (or equivalent experience) in Automation... certifications include SANS/GIAC (GICSP, GRID, GCIP), ISA/IEC 62443 Expert, CISSP, or relevant network infrastructure credentials...
as required. Work and adhere to quality standards for ISO 9001, ANSI/NCSL Z540-3, and ISO/IEC 17025 Keysight quality program. Assist..., and ISO/IEC 17025. Requires ability and desire to learn system/automated calibration software. Ability to calibrate...
Business Enterprise, ISO/IEC 27001, SOC 2 Type 2 certified company with massive 18+years of diversified experience...