Daniel Munguia Chang

Quality manager for development and market introduction of medical devices including medical device software (AI), digital operating rooms and diagnostic displays; led quality/risk activities for regulatory compliance and product launch since Aug 2024.

Software developer for an in-vitro diagnostic device measuring multi-antibiotic resistance; contributed firmware and application code to drive diagnostic measurement features between Mar 2023 and Aug 2024.

Developed integration solution to connect hospital monitoring systems with external medical devices during Jan–Mar 2023, enabling reliable data exchange and interoperability in clinical environments.

Led software development and was responsible for embedded firmware for hospital ventilation systems from Jun 2021 to Jan 2023, delivering reliable real-time control and safety features for clinical ventilators.

Responsible developer for embedded firmware controlling a pneumatic system for nerve-tissue treatment, delivering device control and safety validation between Nov 2020 and Nov 2021.

Validation engineer for administrative integration software including FDA 21 CFR 820 medical device software from Apr 2021 to Oct 2021, performing verification/validation and conformity assessments.

Planned QA and regulatory activities for a medtech startup (May–Jul 2021), advising on AI Act implications and MDR compliance for medical device software.

Developed software to automate pipetting robots and IVD instrumentation for HIV analysis and contributed to system automation from Aug 2018 to Jul 2020.

Led development of transport solutions for heavier IVD instrumentation from Jun 2018 to Jul 2020, managing hardware design and project delivery.

Provided project planning and QA consultation for healthcare projects in Region Västmanland, focusing on software quality, testing practices and Visual Studio-based development workflows in 2021.

Activities and societies: Master thesis collaboration with Nagoya University on sensor data visualization and wrist load assessment.

Master's degree in Medical Technology with a thesis on smartphone acquisition and online visualization of IMU and EMG sensor data for assessment of wrist load, conducted with Nagoya University.