with generating, maintaining, and updating Design History Files (DHF) for new and/or existing products. - Completes all work...
work will focus on performing Design History File (DHF) remediations, writing Procedures and Test Method Development.... Projects Include: Project 1 – Assisting with Developing PRCDs for Internal DVT Project 2 – DHF Remediation for Commercial...
and translate findings into subsystem requirements. Ensure control measures flow into the Risk Management File and DHF. Translate...
, and regulatory requirements for Class II electronic medical devices. Proven mastery of design documentation (DHF/DMR) and experience...
, DHF, traceability matrices) through data gathering, drafting, and revision. Contribute to assembling and testing...
, human factors, regular review of DHF, combination product launch activities, device product complaints, and post-market...
and DHF documentation. Perform hardware/software/lab tests;Ensure compliance with ISO 13485 standards. Communicate status... and DHF documentation. Perform hardware/software/lab tests;Ensure compliance with ISO 13485 standards. Communicate status...
. Maintain requirements traceability and Design History File (DHF) documentation. Perform hardware, software, and laboratory...
, including work instructions, BOMs, routers, FMEAs, DMRs, and DHF documentation Provide technical leadership to engineers...
Support Design History File (DHF) remediation and gap assessments as needed Ensure traceability, consistency, and compliance... Aptitude and Skill Set: Direct experience with DHF remediation, CAPA-driven documentation updates, or site-readiness projects...