walkthroughs, and expert reviews Develop and maintain high-quality documentation in alignment with regulatory standards (e.g., IEC... across R&D teams to deliver world-class user experiences Required qualifications: Bachelor’s or Master’s degree in Human...
Position Overview: Fujifilm Sonosite is seeking a Reliability Engineer to support R&D Systems Engineering developing... following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 60601-2-37. In-depth understanding...
with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Qualifications: Engineering... with IEC 62304 #LI-CD Requisition ID: 615039 Minimum Salary: $ 76000 Maximum Salary: $ 144400 The anticipated...
with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Basic Qualifications... with IEC 62304 Please note this is a hybrid position located in Waltham, MA. #LI-CD Requisition ID: 614825 Minimum...
on product lifecycle management. This role is majority remote but will need to come into an office or R&D facility on a regular..., etc.), and EMS software architecture. · IEC-61131-3 programming language and experience with Codesys, AcSELerator or similar IDEs...
with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Basic Qualifications... with IEC 62304 Please note this is a hybrid position located in Waltham, MA. #LI-CD Requisition ID: 614825 Minimum...
with a cross-functional team and serves as an R&D representative on cross-functional deliverables. Qualifications: Engineering... with IEC 62304 #LI-CD Requisition ID: 615039 Minimum Salary: $ 76000 Maximum Salary: $ 144400 The anticipated...
compliance with FDA 510k, ISO 13485, and FDA 21CFR Part 820 regulations. Working knowledge of IEC 60601-1 3rd Edition... medical device industry, with a focus on R&D, verification, and validation. In-depth knowledge of FDA 510k submission process...
Responsibilities: The successful candidate will work in a dynamic environment as part of an R&D team developing.../standards (IEC, etc.) and internal quality management and design control processes. Prepare DFMEA/PFMEA. Board level test jigs...
. Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure testing covers all aspects..., diagnostics). Working knowledge of FDA regulations, ISO 13485, IEC 60601, ISO 14971, and related compliance standards...