and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred Supporting medical device... compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek Maintenance of technical design...
for a Principal Electrical Engineer for the Strategic Robotics R&D Team. This position is located in Santa Clara, CA.... What We Do: The Strategic Robotics R&D team envisions a future for robotic intervention that is targeted, minimally invasive...
tasks. Experience with at least one Data analysis tool (e.g.: Excel or R). Willingness to work in a fast-paced... of Quality in Medical Devices (ISO 13485, ISO 14971, IEC 62304, and IEC 62366), and FDA’s 510(k) process. Experience...
. Collaboration & Communication: Collaborate with cross-functional teams, including IT, R&D, Operations, Marketing, and Technology... with national cyber security standards (e.g., NIST, ISO/IEC 27001). Strong analytical, project management, and problem-solving...
, operational and safety standards such as IEC-62638, EN54-24, UL1480, UL1480A Work in a team environment with project managers.... Ability to problem solve and innovate as part of an industry leading R&D team. Ability to travel up to 25% internationally Preferred...
Job Description: This is a highly technical role inside the CooperSurgical R&D New Product Development (NPD) group...'s purposeful setting of integrated Front-end Innovations and New Product Development provides an exciting opportunity for R...
in Python -Demonstrate experience in data post-processing, statistical analysis and presentation, via R / Matlab / Python...). -FDA 21 CFR Part 820 – FDA Quality System Regulation preferred -IEC 60601-1 – Safety standard for electro-medical devices...
standard deductive (FMEA, FMEDA...) and inductive (H&R, FTA) methods, the outcomes of these analyses will inform to the system... experience in applying safety according to ISO Client 26262 standards, or secondly IEC 61508 standard. Prefer a good...
. Collaboration & Communication: Collaborate with cross-functional teams, including IT, R&D, Operations, Marketing, and Technology... with national cyber security standards (e.g., NIST, ISO/IEC 27001). Strong analytical, project management, and problem-solving...
engineering Experience with compliance and agency approval processes Experience with UL or IEC standards Bachelor's degree... and engineering in a non-union shop. There is potential for growth into R&D management roles. Pay and Benefits The pay...