evaluations (DOEs) and providing technical input for justification of project and design. Responsible for contributing to the DHF...
activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides...
frameworks such as ISO 13485, FDA QSR, IEC 60601, ISO 14971, ASTM standards, DHF, FMEA, and V&V protocols. Experience...
Management File (RMF) and associated Design History File (DHF) documents. Ensure risk-related documentation is complete...
plans, protocols and reports. Perform DHF/DHR/DMR reviews for product release. Provide quality expertise post-market...
activities for electromechanical systems with microcontrollers, PCBs, and software components. Manage Design History Files (DHF...
Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF...
years of experience in DHF gap analysis / remediation for medical devices. Strong hold on medical device lifecycle... as per industry standards. Knowledge of FMEA (Design, Process, System). Knowledge of DHF and DMR preparation. Sound Regulatory...
). Maintain and review design history files (DHF) and risk management documentation per ISO 14971. Serve as a Quality lead...
13485, or AS9100). Support and review Product Development deliverables as per DHF. Investigate and resolve design-related...