Principal Automation/Robotics Engineer, Cell Therapy
system architectures, user requirements, and design documentation (URS, PFD, FDS, FMEA, DHF, traceability matrices...
system architectures, user requirements, and design documentation (URS, PFD, FDS, FMEA, DHF, traceability matrices...
, and approve system architectures, user requirements, and design documentation (URS, PFD, FDS, DHF, traceability matrices...
responsible for DHF maintenance, design reviews, risk management (ISO 14971), verification/validation strategy, and software...
standards. Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix...
control activities and ensure documentation supports regulatory readiness. Contribute to DHF, technical documentation...
: 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...
: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
manufacturing, conducting product verification/validation, and developing DHF documentation and test protocols compliant with FDA...