Anindita Sengupta

★ Quality & Regulatory Leadership Held final accountability for Quality and Regulatory across multiple novel Intravascular Lithotripsy (IVL) electromechanical medical device platforms, spanning design, supplier, clinical, and software quality, as well as global regulatory strategy. Ensured quality governance and compliance while driving product excellence across pre-market and post-market activities. ★ Executive Partnership & Strategy Served as a core member of the startup leadership team, partnering with R&D, Manufacturing, Operations, and Clinical to define development strategy, regulatory pathways, and organizational priorities across the full product lifecycle. Shaped portfolio-level decisions and risk management to enable rapid innovation and alignment across functions. ★ Quality Systems, Regulatory Execution & Clinical Impact Built and scaled a compliant yet agile Quality Management System (ISO 13485, FDA QMSR) to support early-stage innovation and growth. Completed internal audits, established performance standards for CMOs, and implemented continuous improvement initiatives. Led global regulatory submissions and agency interactions, enabling clinical trials and product advancement. Delivered multiple successful milestones, a 30-patient First-in-Human study on one platform, and a global pivotal clinical trial on another, accelerating product translation and clinical validation.

★ Led Pre-Market & Released Product Engineering for Cardiac Surgery Business Unit Led a 24-member pre-market and released product quality organization across six Class II/III cardiac surgery platforms (hardware, software, combination products) with overall responsibility for design, supplier, clinical, and software quality across global sites. Partnered with R&D, Manufacturing, and Regulatory to define portfolio strategy, set organizational priorities, and drive governance across the full product lifecycle. ★ Strategic Leadership & M&A Integration Directed design control due diligence and integration for three major M&A acquisitions, enabling compliant design transfer, regulatory approvals, and global commercialization. Oversaw staffing, budgets, and performance management, fostering a high-performing, high-engagement team culture. ★ Design Excellence, Regulatory Execution & Product Launches Championed predictive engineering, Design for Reliability & Manufacturability (DRM), Six Sigma, and risk management (ISO 14971/FMEA), leading to > 95% product reliability and significant improvement in design verification outcomes. Served on FDA and Notified Body audits, successfully defending multiple Design History Files. Delivered multiple successful product launches, accelerating regulatory clearance and commercialization timelines.

★ New Product Development & Design Quality Leadership Senior quality leader driving design controls for complex cardiac and cardiovascular devices, including surgical heart valves, single-use perfusion systems, atrial fibrillation devices, and capital equipment. Led design verification and validation, test method validation, design reviews, and end-to-end risk management (Hazard Analysis, Use/Design/Process FMEAs). Championed Design for Reliability & Manufacturability (DRM) and standardized best practices to improve product reliability and reduce customer complaints. ★ Released Product & Lifecycle Management Provided engineering and regulatory leadership for released products, leading compliant design changes and continuous improvements aligned with EU MDR. Integrated complaint trending and post-market surveillance into Quality Management Reviews to proactively manage risk across design, process, and supplier changes. ★ Leadership & Organizational Impact Built and scaled a high-performing pre-market engineering organization from 7 to 21 team members, including people leaders. Fostered a culture of accountability, inclusion, and technical excellence. Led organizational transformation through change management, career progression frameworks, and mentoring programs, increasing organizational health scores by over 15 points to world-class levels (>80%). ★ Quality Systems & Regulatory Engagement Key contributor to global Quality System transformation initiatives, strengthening lifecycle compliance with worldwide regulations. Trusted quality partner for internal and external audits, including FDA and MDSAP inspections.

★ Product Development: Coordinated end-to-end development and commercialization of cardiovascular medical devices, overseeing all phases from initial design to market launch, contributing to the business unit’s ECLS growth portfolio. Navigated pioneering regulatory pathways for new product indication approval of ECLS products. ★ Customer Engagement and Research: Engaged with medical professionals for critical voice of customer sessions and validation studies, aligning product development with precise clinical requirements, ensuring delivery of clinically reliable and user-centric products ★ Technical Leadership: Supervised extended teams in developing and executing comprehensive design requirements, test methods, and verification and validation strategies, guaranteeing alignment with customer and regulatory expectations. Developed unique static and dynamic test methods for design verification testing of device long term use ECMO devices ★ Project Management: Managed scope, timing, and financial aspects of product development projects, maintaining optimal resource allocation and on-time, within-budget delivery, boosting overall project efficiency and profitability. Led core team meetings, delivered regular status updates to senior management, PRC, project teams, and the broader organization, ensuring clear communication and alignment on project progress and milestones. ★ Team Building and Mentoring: Mentored junior engineers and project team members, cultivating a collaborative environment and guiding in aligning efforts with clear project goals, roles, and tasks, culminating in strengthened team capabilities and performance. ★ Leadership and Professional Growth: Completed nominated Enrich leadership program, acquiring leadership and strategic skills crucial for managing complex product development projects and fostering collaborations across cross-functional teams.

★Innovative Product Leadership: Lead new product developments as Core Team Lead/Member across multiple technology platforms including implantable medical devices like heart valves, structural heart devices, minimally invasive electromechanical single-use disposables, ablation catheters, delivery systems. Performed requirements development, risk management, design verification, software validation. Managed a team of 4 junior engineers. ★External Collaboration: Conducted technical triage and implemented problem-solving techniques, including enhancements to Contact Force Ablation Catheter and modifications to electrophysiology catheter tip bond and buckle force (column strength) in collaboration with the FDA. Partnered with Physicians and end users for Voice of Customers, product refinement, animal studies and clinical trials. ★ Lean Initiatives and Cost Optimization: Led lean initiatives and continuous improvement strategies, optimizing manufacturing processes and enhancing operational efficiencies, yielding an 8% reduction in running costs for a central product family. Conducted Kaizen events, implemented cellular flow manufacturing, developed standard work for production efficiency improvement by upto 32%. Improved NCMR reduction by 900% after implementation of 5S, Kanban, Quality Circles and line clearance activities ★ Change management and leadership: Lead complex projects with large cross-functional teams accomplishing OPS transformation, M&A integration, international production transfers, capacity expansions, integration of newly acquired business in highly regulated industries. Managed direct reports through multiple mergers and acquisitions ★ Quality System: Implemented quality system improvements across various areas, including risk management, clinical product development processes, test method development and validation, design inputs and outputs, and design verification and validation. Owned CAPAs and NCMRs

★ Design Engineering: Supported complex design pacemaker leads from concept to verification testing including requirements development, clarification and testing coupled with detailed CAD drawings, improving product detail and accuracy, leading to refined manufacturing processes. Developed and validated test method ★Statistical Analysis and Method Development: Conducted advanced statistical data analysis and sampling plans, designing novel test methods, optimizing measurement systems and guaranteeing product quality. ★Problem Solving: Performed root cause analysis resulting from design testing using six sigma methodologies