and maintain customized product specifications and Design History Files (DHF), while driving technical reviews with supportive data...
). Experience with design controls and documentation in a regulated environment (FDA, ISO 13485), including DHF creation, risk...
and regulatory compliance. Prepare and review Design History Files (DHF), Device Master Records (DMR), and related technical... validation. Hands-on experience leading design reviews and addressing CAPA or audit findings. Knowledge of DHF/DMR structure...
. Document clinical studies plans/ reports for inclusion into the Design History File (DHF) project. Interact as the primary...
creation and maintenance of DHF documentation and oversight of technical resolution activities. Technical product team lead... DHF files and reports for new and existing products. Lead or oversee the technical design of product components based...
and risk-based decision making Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA Risk as part of design change...
components and integration. What You Will Bring: Good Knowledge of GE DHF on both Software and H/W development process...
and approve Design History File (DHF) documents, ensuring compliance to design control requirements. EDUCATION & EXPERIENCE...
for DHF(design history file) and to support FDA submissions. You will have the opportunity to work on challenging projects...
. Maintain design documentation such as DHF, specifications, drawings, and risk files. MPI does not discriminate on the basis...