device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR, and corporate procedures... knowledge of global regulatory requirements for medical devices (21 CFR Part 820, ISO 13485, EU MDR, IEC 62304). Experience...
, protocols, and reports in compliance with FDA 21 CFR 820 and IEC standards. Perform system-level, integration, and safety... with R&D, Systems, Manufacturing, and Regulatory teams. Support audits and regulatory inspections through well-documented...
with hardware, firmware, software, and systems teams in a highly cross-functional, regulated R&D environment to deliver reliable... environments such as FDA, IEC, or ISO End-to-end FPGA ownership from architecture through validation Experience debugging real...
certification standards (e.g., ISO/IEC 17024, ANSI/ASTM standards) Knowledge of psychometric principles and exam development... processes Familiarity with accreditation procedures Experience with R and SQL Experience with certification analytics...
) Adhere to our Quality Management System and ISO/IEC 17025:2017 Support the maintenance of our ISO/IEC 17025:2017..., etc. Experience participating in ISO/IEC 17025:2017 accreditation audits Additional details: This role will require travel...
etc Job Description Coordinate with the India Engineering Center (IEC) and enable successful project execution and have a daily sync with the... offshore team and IEC leadership Perform a full lifecycle product development (Design, Develop, test prototypes, and implement...
responsible for supporting pre-market project teams in building security deliverables. You will work with R&D teams to help them... - Familiarity with the OWASP Top 10 - Familiarity with standards such as IEC 81001-5-1 and IEC 62304 Responsibilities may include...
deliverables. You will work with R&D teams to help them understand how to build products securely by design and how to maintain... Familiarity with standards such as IEC 81001-5-1 and IEC 62304 Experience with threat modeling Experience with SBOMs (Software...
and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971) Use-related Risk analysis Education and Experience... to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems...