Philippe Berube
Independent Consultant Medical Device Software Engineering
About
Education
Universit de Sherbrooke
Bachelor of Software Engineering / 2000
Experience
Confidential Client (Ocular Disease Diagnostic Device)
Independent Consultant / -1 — Present
Led cybersecurity risk analysis for both the medical device and its cloud-based software application. Authored full cybersecurity documentation package for FDA Pre-Market submission. Reviewed software risk analysis and validated regulated SaaS tools (Jira, BitBucket, eSign).
Confidential Client (Radiotherapy Solutions for Cancer Care)
Independent Consultant / -1 — Present
Supported product teams as Medical Device Software specialist on regulatory strategy alignment. Structured technical file for both FDA 510(k) and EU MDR submissions. Reviewed requirements safety analysis and test traceability processes. Developed Python-based tooling for software testing automation.
Confidential Client (Cardiovascular Diagnosis Treatment Device)
Independent Consultant / -1 — Present
Led user and software requirements risk analysis and full traceability. Defined software validation processes in accordance with ISO 13485. Validated ERP system and electronic signature application for regulated use.
Confidential Client (Oxygen Therapy Device)
Independent Consultant / -1 — Present
Authored software development plan architecture and design documents for FDA 510(k) submission. Authored software development and maintenance SOP. Reviewed software risk management table and generated traceability matrix. Executed and maintained unit tests for firmware application.
Confidential Client (Cardiac Monitoring Device)
Independent Consultant / -1 — Present
Authored and reviewed IEC 62304 documentation for Class B software applications. Conducted compliance review and gap analysis against IEC 62304. Authored software risk management plan and reviewed VV plans. Performed SOUP hazard analysis traceability and cybersecurity risk analysis. Validated SaaS tools (Jira) used in ISO 13485 QMS context: plan risk analysis test protocols execution report.
Confidential Client (Human Gait Assistance Device)
Independent Consultant / -1 — Present
Reviewed and executed verification and test protocols for firmware and Android tablet applications. Authored verification report for firmware and Android applications. Delivered full SOUPOTS validation package: validation plan risk analysis and report. Fixed bugs and implemented features in firmware application.
Confidential Clients (Multiple Devices)
Independent Consultant / -1 — Present
IEC 62304 FDA 510(k) compliance reviewer across the following device types: Sustainable diagnostic imaging (X-ray) system; Dental imaging system; Orthodontic AI-powered monitoring system; Smart tracking devices for orthopedic surgery instruments; Real-time imaging device; Radiotherapy quality control device.
Neurostream Technologies
Technical Lead Software Engineering / 2010 — 2012
Led a team of 7 software engineers through IEC 62304 Class C software development and verification for an implantable neurostimulator. Designed and implemented software development and verification plans; served as technical and quality reviewer. Established a process for validating software tools in accordance with US and EU regulations. Developed automated build system for software application deployment.
Software Engineer / 2004 — 2010
Principal engineer for firmware of the Neurostep implantable neuro-stimulator (gait disorder treatment): real-time gait detection nerve sensing and stimulation synchronization (C TI MSP430]. Full ownership of requirements architecture design specs risk analysis (DFMEA) coding unitfunctional testing and traceability. Developed embedded software for battery recharge control (C Atmel AVR] and simulators for artificial muscle and motorized ankle (C++ Matlab].
Handyem
Software Engineer / 2012 — 2015
Developed signal processing and data acquisition applications on Xilinx Microblaze core (C C++). Built automated test system and test bench for algorithm characterization (Python Robot Framework Jenkins). Developed client-server application for cytometer device control (C++ Clojure JavaScript Linux).
AxesNetwork
Project Manager Senior Software Developer / 2015 — 2020
Designed and built IoT infrastructure and cloud-connected backend microservices (ASP.NET Core Python Flask Docker REST). Developed backend in JavaAKKA interfacing with MongoDB and RabbitMQ for IoT-to-cloud data pipelines. Implemented CICD pipelines (Azure DevOps) and remote monitoring (Zabbix Elasticsearch). Designed and manufactured PCBs for contactless RFID card readerwriter.
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