Ashwini Kumar Email & Phone Number

Cary, Nc, Us

Responsible for supporting cross-functional core team members in the software product design and development lifecycle for an innovative digital diagnostics portfolio of new offerings that use machine learning and AI technology to improve clinical outcomes. The goal of the team is to Our goal is to provide high-quality, reliable, and regulatory-compliant software products to support worldwide market release in meeting the needs of clinical customers, patients, and Beckman business growth objectives.

Cary, North Carolina, United States

Mumbai, Maharashtra, India

Cary, North Carolina, United States

Principal Consultant Quality Management Systems: Developing and implementing robust QMS frameworks, conducting audits, and providing strategic guidance for continuous improvement. Using expertise in software development, ISO standards, and process optimization to drive excellence in product and service quality. (ISO 9001, ISO 13485, ISO 27001, Regulatory pathway for products with AI and ML capabilities)

Created company-wide product quality operations and strategy for the design, development,and commercialization of Digital Therapeutics (DTx) Software as a Medical Device (SaMD)• Established GMP quality systems for a 30-member agile development team, implementedoverall risk management and product quality strategies, including all aspects of ISO 14971,IEC 62304, IEC 62366, AAMI HE75, and relevant FDA guidance for requirements management,requirement traceability, risk analysis, risk evaluation, test management, human factors(Usability), design control, document control, and change management• Implemented eQMS and established the end-to-end process for Design Control, RiskManagement, Training, Post-Market monitoring, Complaint Handling, CAPA, and SupplierManagement, upholding patient safety, product effectiveness, and regulatory compliance• Led product quality-related regulatory documentation and deliverables, SOPsand Work Instructions, for De-Novo Breakthrough FDA submission and commercialization,including all safety reporting requirements• Conducted internal audits of Verification and Validation protocols, TraceabilityMatrix, Usability (HF) Evaluative and Summative protocols and cybersecurity requirements• Implemented continuous improvement initiatives to enhance the quality and efficiency ofproduct development process (bug reporting, design change control & complaint handling)

Mumbai, Maharashtra, India

To scale and optimize solutions, technology plays a critical role. In my role as the Head of Digital Transformation at RISE Infinity Foundation, bringing my vast expertise in software engineering, LEAN development, and risk management, and utilizing these skills to ascertain the value of products, programs, and processes, I have deployed affordable digital tools at social-impact organizations, to optimize their operations, evaluate the impact, and communicate outcomes.● Created a UNICEF M&E data collection app and deployed a dashboard with 500+parameters, in less than 3 months, with 100% adoption by 230 rural users in Maharashtra,India. (https://mahac19peconet.org/co-marg-dashboard/)● Designed, led, and monitored a 6-month program to combat vaccination hesitationand deployed help desks in slums, impacting 300,000+ vulnerable citizens● Led RISE World Summit 2021 and 2022, a phenomenally successful virtual summit; 4700+participants from 55 countries engaged in 100+ events (https://www.risesummit.in/)

Pune, Maharashtra, India

Designed and implemented medical device software quality management systems incompliance with regulatory standards (FDA 510(k)/ PMA, EU-MDR, ISO 13485, IEC 62304)● Led device regulatory compliance and quality system on multimillion-dollar, cross--functional, global projects for 5 international clients across the US, Europe, and India● Managed teams of up to 8 members to deliver QMS and V&V for 5+ products classifiedas Class II SaMDs (with AI) and firmware-based MDs, using automation tools andsystems for risk management, requirement traceability, and test development● Hands-on experience in gap assessments, traceability, design history files (DHF & TF),QMS documentation, expert reviews (SME), predicate device establishment, CAPA,complaint handling, configuration management, algorithm testing with AI and MLcapabilities, process validation, and software verification & and validations● Led teams transitioning to MDR 2017/745 for Class II & III medical device manufacturers● Led Class II & III device projects in Cardiology, Neurology, and Image Diagnostics

United States

Firmware V&V lead for R&D projects of complex Class III implantable cardiac devices,working within highly cross-functional teams using automation tools and methodologies● Led Software V&V and quality assurance on new products, with active involvement inwriting and analyzing system specifications, validation strategies, hazard mitigation● Managed 10 member teams (offshore and onshore) leading formal verification andvalidation activities needed for FDA submissions, risk management, FMEA and CAPA,on 30+ modules on 8 product families, while working with highly cross-functional teams(research, marketing, systems, risk management, firmware & UI development, toolvalidation, QA, regulatory, clinical)● Developed automation tests and systems using Python, MATLAB, and other in-housebuilt tools and simulators; expert in designing and tracing requirements for complexdevices● Interacted extensively with cardiologists and medical research teams to gatherVOC needed for system and software design and requirement traceability● Selected to represent embedded V&V team at an innovative Agile cross-functionaltask transforming how cross-functional teams work by making them product-centric.Implemented visual management systems to communicate status with minimal effortfor both the team and upper management

Www.Vibha.Org

Bangalore, India

Led Software V&V for devices such as blood infusion pumps (Class III) and Blood Gasanalyzers (Class II)

Mysuru Area, India

Education record

Mba, Operations Management

Be, Medical Electronics

Activities and Societies: Co-Founder and Vice-Chair, Impulse (Medical Electronics Forum), DSCE

High School