, memory/cache strategies) Understanding of safety and/or security certification processes (DO 178C, ISO 26262, IEC 61508... for embedded) Familiarity with safety certification standards such as DO 178C, ISO 26262, IEC 61508, and system safety processes...
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...
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...
Engineers, and other R&D personnel. This position requires embedded software engineering skills in the implementation... from product to design and test cases. Working with functional safety compliance processes (e.g. IEC 61508 and/or IEC 60730-1...
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...
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 MDR, MDCGs, ISO 13485, ISO 14971, IEC 62304, IEC 60601 and Alcon Quality System. Responsible for local implementation... Review Reports. Leading Design Phase Reviews. Collaborating with R&D Lead and rest of Core team to assemble design review...
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...
of regulatory requirements (FDA, IEC, ISO) and quality management systems. Demonstrate skills in “systems thinking†– ability... to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every...
Method Validation (TMV) (i.e., Gage R&R Studies) and Inspection Method development activities. Perform other quality-related... with applicable standards: ANSI, ASTM, MIL, IEC test methods. Skilled in the use of precision hand tools for mechanical...