frameworks including UN, IEC, UL, SAE, ISO, and regional requirements to client programs Serve as a technical authority... Expertise Act as a subject matter expert across battery and ESS standards, including but not limited to: UN 38.3, IEC 62281...
Overview Join Element’s Santa Fe Springs CA team, an FDA-registered, ISO/IEC 17025-accredited facility specializing..., and technical requirements. Interpret and communicate complex testing protocols, regulatory requirements (FDA, ISO/IEC 17025...
on time and within budget. Cross-Functional Coordination: Serve as the primary interface between R&D, engineering, clinical.... Strong knowledge of regulatory and quality standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971 and IEC 62304. Experience...
and successful transfer into manufacturing. You will collaborate across R&D, regulatory, manufacturing, planning, procurement, and quality... collaboration, innovation, and continuous improvement. Partner with R&D, quality, regulatory, supply chain, and manufacturing teams...
engineering activities are planned, executed, and reported in accordance with relevant standards (IEC 62366, ANSI/AAMI HE75, FDA... Familiarity with global human factors guidance and regulatory standards (e.g., IEC 62366, ANSI/AAMI HE75, FDA Human Factors...
and architectural vision across R&D and product teams. Maintain expert knowledge of product use in clinical practice and leverage... of medical devices, FDA QSR, ISO 13485, and relevant risk and electrical safety standards (ISO 14971, IEC-60601-1/1-2...
in a role which required knowledge of MIL-STD-704, MIL-STD-1275, MIL-STD-461, MIL-STD-464, DO-160, IEC-61000, and/or FCC part 15... U.S. export control compliance requirements, a "U.S. Person" as defined by 22 C.F.R. 120.62 is required. "U.S. Person" includes...
in a role which required knowledge of MIL-STD-704, MIL-STD-1275, MIL-STD-461, MIL-STD-464, DO-160, IEC-61000, and/or FCC part 15... U.S. export control compliance requirements, a "U.S. Person" as defined by 22 C.F.R. 120.62 is required. "U.S. Person" includes...
in a role which required knowledge of MIL-STD-704, MIL-STD-1275, MIL-STD-461, MIL-STD-464, DO-160, IEC-61000, and/or FCC part 15... U.S. export control compliance requirements, a "U.S. Person" as defined by 22 C.F.R. 120.62 is required. "U.S. Person" includes...
(plans, protocols, reports) in compliance with FDA and IEC 62366 guidelines. Collaborate with cross-functional teams (R... Responsibilities: The Human Factors R&D Co-Op will: Assist in user research activities to gather data on user needs, behaviors...