Mohammad R.

• Lead end-to-end system design and NPI execution for OrthoGrid Hip AI 4.0 (Class II AI-enabled SaMD) as Product Owner, managing a team of 4 engineers. • Drive design inputs, risk management, and software lifecycle activities aligned with IEC 62304 including V&V, and usability engineering to support compliant product development and regulatory submission. • Own and ensure integrity of the Design History File (DHF), maintaining complete traceability across user needs, design inputs, risk files, and V&V artifacts in alignment with QMS and regulatory requirements. • Own design control strategy and execution across D&D planning, V&V, and ISO 14971–compliant risk analysis (uFMEA, SWFMEA, SOUP/OTS) • Lead and execute formative and summative usability evaluations, including cadaver-based studies, ensuring compliance with IEC 62366-1 and integration of usability findings into design inputs and risk controls. • Author and review technical documentation across the DHF (e.g., User Manuals, V&V protocols/reports, and regulatory submission content), ensuring alignment with design inputs, risk controls, and traceability, and supporting FDA 510(k) compilation and submission.

• Owned design controls, DHF creation, and eQMS (GreenLight Guru) management for SaMD N.P.I projects. • Translated user needs into design inputs and assessed feasibility; created project schedules while coordinating engineering resources. • Drove verification activities, regression testing, and ensured full traceability across DHF artifacts. • Reviewed and contributed to risk management files; led risk analysis activities and brainstorming sessions.

• Translated user needs into design inputs and supported release planning for Total Hip Arthroplasty and Trauma SaMD platforms. • Created low-fidelity UI/UX workflows to support feature design and usability. • Led project review board meetings to drive stakeholder alignment across engineering, clinical, and regulatory teams. • Translated high-level user needs into researcher-friendly requirements and performance criteria for R&D projects. • Created formal testing reports with results and edge-case illustrations to support design inputs and V&V. • Created official training presentations and videos of software workflows to support surgeon training and clinical evaluation.

• Led design work and managed project scheduling for multiple Class II SaMD platforms (Universal Trauma Platform, Total Hip Replacement Platform, Hip Preservation Platform). • Collaborated with Regulatory and engineering teams on the successful 510(k) clearance of the company’s first Class II device. • Interfaced with surgeons at IRB-approved sites to gather clinical feedback and guide new feature development.