guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF...
experience. Proficiency in Microsoft Office required. DHF design experience highly preferred. CAD experience highly preferred....
best practices through entire corporate PDP Managing efforts for compliance ensure design control, DMR/DHF compliance, risk...
required. 4 or more yearsÂ’ experience. Documentation experience. Proficiency in Microsoft Office required. DHF design...
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...
for contributing to the DHF and regulatory submittals, creating SOP, and for providing training to ensure proper design transfer. 2...
projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology...
, and regulatory requirements for Class II electronic medical devices. Proven mastery of design documentation (DHF/DMR) and experience...
, maintaining, and managing essential documentation such as Design History Files (DHF) and Device Master Records (DMR) Excellent...
performance reviews, and test method validation. Perform DHF audits and mechanical drawing review and approval per ASTM...