Embedded Engineer II
and implement safety-critical features to satisfy applicable regulatory standards (e.g., IEC 60730) and support certification...
and implement safety-critical features to satisfy applicable regulatory standards (e.g., IEC 60730) and support certification...
ECR/ECO;support V&V. Maintain schematics, BOMs, wiring diagrams, and technical docs. Ensure compliance with IEC 60601...
, and applicable IEC standards. Ensure completeness and quality of Design History File (DHF) documentation. Lead and participate...
in regulated development environments such as IEC 62304. Result-oriented, self-motivated and able to participate as both a team...
/standards (e.g., IEC 62443 / NIST concepts) and translating them into practical controls. Hands-on firewall and segmentation...
information security risk management aligned with ISO 27001, NIST CSF 2.0, NIST AI RMF, and ISO/IEC 42001. Conduct technical... for LLM Applications, NIST AI Risk Management Framework (AI RMF), and ISO/IEC 42001, with familiarity in applying these...
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...