Dr. Aleksei Zhdanov

Reviewed software changes for safety relevance, verification need and retest triggers, deriving test scope from ISO 14971, IEC 62304 and FDA 21 CFR‑linked requirements. Designed and maintained requirement‑based tests, aligned selection plans with stakeholders and executed verification in the MR bay. Built AI‑assisted tooling, cut verification scope >50% and prevented ~4.5 bay shifts via impact analysis.

Led technical coordination for the SureWave MRI elastography integration, aligning hardware behaviour, software workflow, system constraints, validation evidence and clinical‑site readiness. Managed dependencies, risks and stakeholder decisions across engineering, system and validation teams. Converted findings into documented actions. Completed integration through pilot readiness and compliance evidence, advancing the device toward CE/FDA routes.

Tested the SureWave MRI elastography device in R&D, assessing compatibility, RF behaviour, performance and integration risk. Performed MATLAB analysis of measurement data and RF‑noise findings, converting raw behaviour into evidence for expert review. Documented non‑compliance scenarios for validation. Resolved a critical RF‑noise issue and built system‑level expertise in MRI hardware, RF constraints and integration risk.

Managed medical‑equipment and medical‑IT projects from technical assessment to delivery, installation, application deployment, acceptance and handover, closing 21 complex projects on time. Assessed technical, financial, supplier, site‑readiness and IT risks, converting them into controls and corrective actions. Coordinated clinical users, specialists, subcontractors and Siemens teams to align delivery, workflows, readiness and acceptance evidence.

As Senior Project Manager (PM), registered and launched cardiology, neonatal, respiratory and diagnostic devices by coordinating engineering, documentation and partner communication; secured USD 1M funding and accelerated sterilisation‑method patenting to 6 months at ~20% of budget. As PM, delivered localisation and OEM programmes by managing suppliers, engineering contributors, risks and compliance packages. As Software Engineer, developed embedded and automation software (STM32, C++, SIMATIC/WinCC).

Dissertation: machine-learning clinical decision support for ophthalmic diagnostics based on biomedical signal analysis.