(Quality, Regulatory, Manufacturing, and Supply Chain). Create and maintain technical documentation Design History File (DHF...
and approve Design History File (DHF) documents, ensuring compliance to design control requirements. EDUCATION & EXPERIENCE...
., DHF) and applies clinical knowledge to create accurate design inputs. Strong foundation in mechanical engineering...
assessments. Act as a divisional expert in applying medical device standards and reviewing design documentation (e.g., DHF...
lean and six sigma initiatives in a regulated environment Led and managed development of DHF (design history file...
Design History File (DHF) updates in collaboration with Development device teams Support the creation and maintenance...
standards. Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix...
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...