Uttariyo Saha

Directed end-to-end CAPA and NCR processes for over two years, successfully closing internal and external audit CAPAs and providing critical support during NSAI and FDA audits.

Partnered in a major digital transformation initiative to expand SAP modules, fully digitizing the purchasing-to-production workflow and enhancing operational efficiency.

Directed change management via QT9 eQMS, successfully executing over 70 cross-functional change controls and managing stakeholder expectations across multiple departments.

Led a Lean Six Sigma Green Belt initiative, optimizing production planning and workflows to achieve a >13% reduction in manufacturing downtime.

Designed and executed a cross-functional storage and transportation study, reducing temperature excursion handling time by 70% and optimizing material on-hold processes.

Acted as Quality's Data Analytics SME, translating QMS events and PMS data into actionable weekly/monthly KPIs and Management Review insights for executive decision-making.

Steered Quality deliverables for the ‘Impress’ device, driving design V&V, DHF completion, and securing FDA 510(k) clearance while overhauling enterprise risk management documentation.

Led clinical and external stakeholder engagement, bridging clinical requirements with manufacturing execution and collaborating with Key Opinion Leaders (KOLs) to validate user needs.

Provided Design Assurance oversight for a Class II medical device New Product Introduction (NPI), ensuring strict compliance with ISO 13485 and ISO 14971 Risk Management standards.

Authored and maintained the complete Design History File (DHF), translating KOL feedback into robust design inputs/outputs and verification and validation (V&V) protocols.

Designed, built, and validated bespoke mechanical and imaging simulators to accurately verify device performance, solving complex technical challenges in V&V testing.

Directed a global prototype testing program for a novel sweat-sensing wearable, orchestrating performance testing and clinical evaluations across international teams and partners.

Conducted deep-dive technical market assessments and competitive benchmarking with the Director, identifying strategic opportunities to shape the product roadmap.

Authored high-impact investor pitch decks, leveraging technical R&D data and market analysis to secure funding from London-based financial stakeholders.

Collaborated with the Head of Finance on financial planning, utilizing Gantt charts to control project budgets and manage technical deliverables across multiple time zones.

Successfully navigated international supply chain bottlenecks, resolving import/export challenges to maintain hardware development schedules across three countries.

Directed end-to-end research operations for smart biomaterial scaffold fabrication, autonomously managing experimental budget, resource allocation, and cross-functional collaboration.

Delivered strategic findings and translated complex biomechanical data into actionable presentations for Principal Investigators and funding bodies, securing alignment on novel computational methodologies.

Developed a complete computational framework for 3D Finite Element Analysis (FEA), accurately predicting anisotropic mechanical behavior of complex structures with a <10% error rate.

Supervised and guided two undergraduate researchers through complex biomaterials and mechanical simulation workflows, ensuring adherence to project timelines and methodological rigor.

Led Biosensing R&D & Data Modeling: Directed early-stage technical R&D for a portable diagnostic device (now commercialized as Mobilab), developing complex mathematical models and calibration protocols to accurately extract and process raw biosensor signals.

Managed Real-World Pilot Deployments: Orchestrated the field testing of decentralized health kiosks in resource-constrained rural centers to gather real-world performance data and drive iterative hardware improvements.

Facilitated Public-Private Partnerships: Secured operational support for rural pilot programs by aligning technical engineering teams with CSR-funded organizations and government health agencies.