Marco Fragnoli

Consulting and interim leadership on software quality, release governance and operational excellence for regulated, safety-critical organisations. Same systems-thinking lens throughout my career: find the friction, design better outcomes. Current engagements include expert-network advisory in the hearing industry.

Progressed from project manager (2018) to Director, Software Quality (2024), operating at the intersection of R&D, Product and Portfolio in a regulated medical-device software context (IEC 62304 lifecycle, design controls).

Trusted by senior R&D leadership to make release-acceptance and product-risk decisions across multiple concurrent programs; Lean Portfolio Management leader steering software investment at portfolio level.

• Product turnaround & root-cause: a newly launched application was failing in the field and the cause had been written off as "human error". I analysed the full defect history, ruled out team negligence, and proved the failures traced back to a systemic gap in the release process. Drove the cross-functional fix; public app-store rating recovered from 2 to 4 stars over ~12 months.

• Data-driven product governance: transformed release and quality decisions from subjective judgement to quantitative risk assessment — customer usage analytics, competitor benchmarking and machine-learning classification of user feedback to rank the product against competitors and to close or postpone defects on real user impact.

• Risk-based defect model: replaced subjective "critical" labels with a company-wide model scoring every defect by severity × probability × frequency-of-use; adopted across all products and still in use after my tenure.

• Portfolio-level steering: approved or rejected epics as LPM leader, leading the portfolio's Business Owners; co-led the multi-year SAFe transformation with the software R&D VP.

• Deep hearing-industry knowledge: the five global manufacturers, differentiation axes, consolidation dynamics, EU MDR / FDA context. Led a distributed team of six across countries.

Led embedded-software and Independent Software Verification & Validation (ISVV) teams. Project lead for the ISVV of the flight software of 2 satellites (11 instruments), working with multiple software suppliers, the prime contractor and the European Space Agency to ensure conformance to ESA standards — including on-site verification and test reviews at supplier and prime-contractor facilities across Europe. Also led embedded development across aerospace, automotive, biomedical and cyber-security products; built a simulator of the ExoMars rover-shield electrical interface (SpaceWire, C++).