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