Staff Device Engineer
product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts...
product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts...
, and approve system architectures, user requirements, and design documentation (URS, PFD, FDS, DHF, traceability matrices...
system architectures, user requirements, and design documentation (URS, PFD, FDS, FMEA, DHF, traceability matrices...
responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software...
control activities and ensure documentation supports regulatory readiness. Contribute to DHF, technical documentation...
standards. Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical Files, Software...
manufacturing, conducting product verification/validation, and developing DHF documentation and test protocols compliant with FDA...