ISO/IEC 12207:2017 in development of system and software engineering life cycle processes Develop, document, manage... for inclusion into customer deliverables Manage development of R&D test automation software development (Python) Ensure alignment...
until the position is filled. We are looking for an exceptional compliance leader to join our R&D team in North America... and sustaining offers with proper interpretation. Interface and collaborate with Global R&D engineering teams providing necessary...
and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls... and IEC 62304 to support work with little or no supervision Applies comprehensive knowledge of software quality concepts...
and testing required to obtain safety, EMC/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC... is differentiating. The engineer will participate in advising R&D teams on development practices, developing test plans encompassing...
/wireless and similar certifications. Experience with the relevant UL, CSA, FCC, IEC and EN directives and standards... will participate in advising R&D teams on development practices, developing test plans encompassing safety, EMC, wireless...
-related issues as necessary. Keep current of MDR regulations and best practices for medical device human factors (e.g. IEC.... NVivo, atlas.ti, SPSS/SAS/JMP/Stata/R). Ability to travel domestically and potentially internationally (up to 40...
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... control compliance requirements, a “U.S. Person†as defined by 22 C.F.R. §120.15 is required. “U.S. Person†includes...
, EU 217/745 (EU MDR) Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601. Experience with risk management... to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every...
such as R&D Engineering, Operations, Quality and Regulatory Affairs. Provide support, as needed, to Clinical Material Release..., and 21CFR Part 4. MDSAP, ISO 9001, ISO 13485, ISO 14971, IEC 62304. In Vitro Diagnostic Medical Device Directive (IVDD) 98...
such as R&D Engineering, Operations, Quality and Regulatory Affairs. Provide support, as needed, to Clinical Material Release..., and 21CFR Part 4. MDSAP, ISO 9001, ISO 13485, ISO 14971, IEC 62304. In Vitro Diagnostic Medical Device Directive (IVDD) 98...