⌘
Software Development & Architecture
C/C++, Python, Qt, C#/.NET, Linux, data services, distributed integration, embedded firmware, hardware interfaces and full-lifecycle design.
SOFTWARE ENGINEERING · REGULATED SYSTEMS · AI
Engineering for systems that matter.
Deep experience in software architecture, medical-device quality, diagnostic imaging, signal processing and technical leadership—now applied to the emerging discipline of AI engineering.
Harmonic Innovations is an independent engineering initiative and developing consulting practice.
ARCHITECTURE / SIGNAL / INTELLIGENCE
SOFTWARE ARCHITECTUREIEC 62304 / IEC 60601IMAGING & SIGNAL PROCESSINGAPPLIED AI ENGINEERING
01 / CORE CAPABILITIES
Software depth.
Systems perspective.
End-to-end technical experience: from algorithm and embedded integration through product architecture, verification, multidisciplinary leadership, and regulatory submission support.
◇
Medical Device Software & Quality
IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality-system work, test strategy, traceability, software V&V and cybersecurity risk controls.
▤
IEC 60601 & Human Factors
Experience relevant to PEMS/IEC 60601-1, usability IEC 60601-1-6, alarms IEC 60601-1-8 and ultrasound IEC 60601-2-37; blood-pressure-related requirements and testing.
◉
Imaging & Signal Processing
Ultrasound, digital radiography, computed radiography, CT integrations and eddy-current NDT, including ultrasonic beamforming, real-time processing, 2D/3D visualization and DICOM/DICONDE.
↗
Technical Program Leadership
Cross-functional and globally distributed teams, vendor delivery, budgets, requirements management, Agile/SAFe and Waterfall execution from concept through validation.
✳
Applied AI Engineering
Local model serving, inference routing, multi-agent development workflows, governance, secure AI adoption and evaluation-oriented automation.
02 / EXPERIENCE & REGULATORY CONTEXT
Built in high-consequence environments.
Neurosurgical navigation system
At inTRAvent Medical Partners, led software/system development and cross-disciplinary coordination for a portable, ultrasound-enabled stereotactic navigation system developed for FDA 510(k) submission. Scope included UI, imaging integration, verification, validation and submission documentation.
Class III device software
At Vitara Biomedical, software leadership has included investigational medical-device architecture, verification and validation, software quality, interdisciplinary integration and regulatory-readiness activities associated with a PMA-track development program.
Not a claim that a PMA has been submitted or approved.GE Inspection Technologies
Led engineering and technical programs across radiographic, ultrasound and eddy-current inspection products serving aviation, energy, automotive and industrial markets. Included a radiography platform program with a reported $3M engineering budget.
03 / CURRENT FOCUS
AI with engineering discipline.
Moving beyond demonstrations to controlled, repeatable engineering workflows.
ARCHITECTURE EXPLORATIONS
Local-first AI infrastructure
On-premises inference, model selection and routing, resource-aware orchestration and integration with existing engineering toolchains.
Agentic development: task-oriented agents, code quality review, independent evaluation and human approval gates.
Governance and security: data classification, boundaries around vendor exposure, locally hosted models and auditable use.
Regulated adoption: practical controls that complement—not replace—established design controls, risk management and validation.
These are current areas of independent engineering exploration, not claims of certified AI products or completed client implementations.
Explore the AI engineering approach ↗04 / ENGAGEMENT AREAS
Independent perspective.
Engineering depth.
Areas for technical advisory conversations as Harmonic Innovations develops its consulting practice. Scope and availability are discussed individually.
AI Architecture & Readiness
Review data classification, model-hosting tradeoffs, architecture boundaries, security risks and evaluation requirements before an AI deployment.
Software Architecture Review
Independent analysis of component boundaries, embedded-to-application integration, performance, maintainability, and technical risk.
Software Quality & Lifecycle
Review software lifecycle processes, IEC 62304 alignment, requirements traceability, risk-control implementation and V&V strategies.
Engineering Program Advisory
Support cross-disciplinary planning, technical milestones, vendor coordination, architecture decisions and development execution.
Services are proposed areas of expertise, not representations of completed consulting engagements, regulatory certification or guaranteed FDA outcomes.
05 / LEADERSHIP
Technical fluency.
Executive perspective.
Andre Maitre brings more than two decades of engineering experience across medical-device software, nondestructive evaluation, imaging systems, technical project management and software leadership.
His background combines hands-on architecture and implementation with global team coordination, risk and quality disciplines, and technical communication across engineering, clinical and executive stakeholders.
He holds bachelor's degrees in Computer Science and History, graduating summa cum laude in both.
LinkedIn profile ↗06 / START A CONVERSATION
Complex systems deserve clear thinking.
For conversations about software architecture, AI adoption, engineering quality or technical collaboration:
Get in touch ↗Contact uses a temporary address until a dedicated Harmonic Innovations mailbox is established. Project experience is descriptive and does not imply employer endorsement.