Lead System Designer

Icometrix; Wilsele; Hybride; EUR 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Hybrid work possible

Learning opportunities

Global impact

Résumé du poste

icometrix, part of GE HealthCare, seeks a Lead System Designer to own end-to-end AI SaMD design, including architecture, risk, and regulatory strategy across global markets. You will drive design controls, V&V, and release readiness while coordinating across Engineering, QA/RA, and Program Management to deliver compliant, scalable solutions.

The role emphasizes cross-border collaboration, AI model decisions, and integration of acquisitions into QMS, with emphasis on cloud-based V&V and

Qualifications

• Master’s degree in engineering, computer science, biomedical engineering, or related field; Ph.D. preferred.
• 5+ years of medical-device or regulated software experience.
• Expertise in deep learning / AI product development (CNNs, LLM / RAG).
• Strong command of Design Controls, requirements / traceability, V&V, and ISO 14971/IEC 62304.

Responsabilités

• Own end-to-end design scope, architecture, and integration plan for AI SaMD.
• Drive design controls and release criteria for build once and deploy anywhere SaMD.
• Participate in AI model training decisions and V&V.
• Lead regulatory strategy across FDA, EU MDR, TÜV; liaise with QMS.
• Collaborate with cross-functional teams across regions; manage risk artifacts.
• Plan verification & validation including cloud-based V&V and DICOM conformance.

Connaissances

Deep learning

AI product development

Design Controls

Cross-functional leadership

Regulatory awareness

Formation

Master’s degree in engineering/CS/biomedical engineering

Ph.D. preferred

Outils

QMS tools

DICOM workflows

Cloud platforms

Description du poste

As part of GE HealthCare, icometrix is a global leader in brain imaging AI software, transforming the management of neurological conditions such as Multiple Sclerosis, Alzheimer’s disease, and Traumatic Brain Injury. Fueled by AI, our FDA-cleared and CE-marked products turn standard brain MRI and CT scans into objective, quantitative data, empowering clinicians globallyThe icometrix team, with headquarters in Leuven, Belgium, includes enthusiastic, team-oriented, and multi-cultural colleagues with a range of technical and medical backgrounds. We enjoy an innovative and challenging working environment and are driven by our core values: impact, trust, collaboration, respect, and crazitivity.https://icometrix.com/Lead System Designer - AI-Enabled SaMD & Platform IntegrationThe Lead System Designer (LSD) owns the end-to-end system design of cloud native AI-based Software-as-a-Medical-Device (SaMD) — from requirements definition through verification, validation, and regulatory clearance.This role sits at the intersection of deep learning product development and regulated design controls, translating clinical and engineering needs into architecture, requirements, risk-managed designs, and release-ready evidence.The LSD leads cross-functional and cross-border teams — Engineering, QA/RA, Program Management, and partner organizations across the US, Europe, China, and India — drives M&A SaMD integration into the GE HealthCare QMS, and applies AI / GenAI tooling to accelerate engineering and regulatory workflows.Key ResponsibilitiesOwn the end-to-end design scope, architecture, and integration plan for AI SaMD with on-prem and cloud offering, including requirements for baselining and the compliance roadmap.Drive the design controls of “API as a product” and define the critical quality strategy, risk, usability and design transfer and deployment for “build once and deploy anywhere SaMD”.Participate in design decisions of AI model training, testing and integration to the host systems.Author and define requirements, lead the RAC / CMT traceability, and design-change plans, defining “ready” criteria for release gates and migrating artifacts into approved QMS tools.Plan and execute verification & validation for SaMD, including cloud-based V&V, software reliability testing, DICOM conformance, and validation-cycle execution against user requirement specifications.Lead risk management artifacts — FMEAs, ISO 14971 risk files, and AI model design controls (IEC 62304 Class C) — and drive CSV reduction and GxP assessment.Serve as the technical focal point for regulatory strategy across global markets (FDA 510(k), EU MDR / TÜV, Korea MFDS / DMPA, NMPA), resolving SaMD-specific questions including EU AI Act, PCCP, AI Conformance Statements, and gap assessments.Drive M&A systems integration of acquired companies into the GE HealthCare QMS —retrospective reviews, DHF / technical-file remediation, and D&D process harmonization.Collaborate with partner-team members, guiding them through GE HealthCare SDLC, V&V, and QMS processes.Represent the program in core team and executive forums, delivering milestone status, QA/RA recovery plans, and design reviews.What do we expect from you?Qualifications and RequirementsMaster’s degree in engineering, computer science, biomedical engineering, or related technical field (Ph.D. preferred).5+ years of medical-device or regulated software experience, including leading NPI programs end-to-end.Demonstrated expertise in deep learning / AI product development (CNNs, LLM / RAG) and the AI SDLC.Strong command of Design Controls, requirements / traceability, V&V, and Quality Management Systems for SaMD (IEC 62304, ISO 14971).Experience with regulatory submissions (510(k), EU MDR / TÜV) and SaMD-specific regulatory frameworks.Proven cross-functional and cross-border leadership across Engineering, QA/RA, and Program Management.Desired ExpertiseHands-on GenAI tooling (Copilot Studio, RAG pipelines) applied to regulated documentation and automation.M&A / third-party integration into a regulated QMS.DICOM / medical-imaging workflows and cloud-based V&V architecture.Systems-thinking approach with the ability to model workflows and identify AI leverage points.Success MeasuresOn-time delivery of milestone-critical SaMD releases (FDR gates) with zero gating action items.Regulatory submissions cleared / approved with high package quality.Reduction in verification / documentation cycle time through AI-enabled automation.Successful QMS integration of acquired products with no silent recalls and audit readiness.Standardized, reusable design / verification artifacts adopted across NPI teams.What do we offer you?Lots of learning opportunities, especially regarding cloud computingA lot of freedom and collaboration with a diverse set of nice colleagues.Hybrid work possibleA market conform wageA job advancing healthcare and technologyA job in an innovative, growing company with a worldwide impactApplicants must be currently authorized to work in Belgium. Visa sponsorship is not available for this position.