requirements, including test method validation Conduct thorough reviews and audits of Design History File (DHF) documentation...
, including DHF elements, specifications, and test protocols. Lead and coordinate supplier qualification, incoming inspection...
best practices through entire corporate PDP Managing efforts for compliance ensure design control, DMR/DHF compliance, risk...
across cross-functional teams Key Skills Design Controls Risk Management (FMEA, Hazard Analysis) Design History File (DHF...
collaboration. You’ll contribute to the creation of Design History Files (DHF), risk management files, and other engineering... Assist in developing and maintaining Design History Files (DHF) and Risk Management Files for medical devices and combination...
required. 4 or more years experience. Documentation experience. Proficiency in Microsoft Office required. DHF design...
across cross-functional teams Key Skills Design Controls Risk Management (FMEA, Hazard Analysis) Design History File (DHF...
across cross-functional teams Key Skills Design Controls Risk Management (FMEA, Hazard Analysis) Design History File (DHF...
, and regulatory requirements for Class II electronic medical devices. Proven mastery of design documentation (DHF/DMR) and experience...
for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design transfer. 2...