(Quality, Regulatory, Manufacturing, and Supply Chain). Create and maintain technical documentation Design History File (DHF...
lean and six sigma initiatives in a regulated environment Led and managed development of DHF (design history file...
., DHF) and applies clinical knowledge to create accurate design inputs. Strong foundation in mechanical engineering...
Design History File (DHF) updates in collaboration with Development device teams Support the creation and maintenance...
assessments. Act as a divisional expert in applying medical device standards and reviewing design documentation (e.g., DHF...
responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software...
system architectures, user requirements, and design documentation (URS, PFD, FDS, FMEA, DHF, traceability matrices...
product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts...
standards. Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix...
controls are properly implemented and verified. Review and approve design documentation, including Design History Files (DHF...