., DHF) and applies clinical knowledge to create accurate design inputs. Strong foundation in mechanical engineering...
Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards...
control activities and ensure documentation supports regulatory readiness. Contribute to DHF, technical documentation...
PCB processes. In-depth knowledge of IEC 60601-1, ISO 13485, ISO 14971, and Class II regulatory pathways. Strong DHF/DMR...
Fundamental knowledge of Medical Device Design Control (DHF, EU MDR, CE Mark) Strong data analysis skills and experience (Minitab...
Fundamental knowledge of Medical Device Design Control (DHF, EU MDR, CE Mark) Strong data analysis skills and experience (Minitab...
to ensure reliability, environmental, and transportation DHF deliverables through Design Control process, plans, verifications...
analysis and DHF maintenance), using advanced inspection, testing, and statistical analysis methods to ensure product precision... for product changes, design change analysis, and Design History File (DHF) maintenance. Demonstrates strong expertise in risk...
projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology...
and maintain customized product specifications and Design History Files (DHF), while driving technical reviews with supportive data...