Adarsh Kothari

Personalized training and consulting for design quality and regulatory compliance in medical devices.

• Ensured overall product quality, stability, and predictability of the scanner system using monthly KPI metrics.
• Successfully executed the plan to set up, transition, and operationalize the new manufacturing unit.
• Mitigated risks and issues during transition and post-go-live by developing and implementing effective mitigation plans.
• Tracked key production and quality metrics through regular governance meetings with the manufacturing unit. Collaborated with cross-functional teams on design, prototype, development, and documentation in DHF.
• Led design reviews of hardware prototypes and new feature designs for R&D projects, driving innovation and improvement.
• Facilitated CCB meetings to discuss hardware design changes and new features, ensuring stakeholder alignment.
• Fostered positive and engaging relationships with stakeholders, internal customers, and project teams, promoting effective communication and collaboration.
• Ensured QMS compliance and met Regulatory requirements for R&D and Manufacturing, maintaining the highest standards of quality and safety.

• Oversaw all technical aspects of device development, including design, prototyping, manufacturing, testing, and documentation in DHF.
• Developed and managed project plans, ensuring timely delivery of project objectives through scheduling, risk mitigation, and resource management.
• Provided real-time project performance insights through summary reports, enabling data-driven decision making.
• Prepared, presented, and archived Design Control reviews and project deliverables to support project objectives.
• Served as Single Point of Contact (SPOC) for customer-reported issues, driving CCB meetings and implementing design changes and new customer requests.
• Drove continuous improvement through trend reporting, metrics management, and actionable insights.
• Fostered positive relationships with project sponsors, stakeholders, internal customers, and project teams to ensure collaborative success.
• Ensured QMS compliance and regulatory requirements for R&D projects, maintaining a high level of quality and adherence to standards.
• Represented R&D in Management review meetings and Annual project budgets, providing strategic input and guidance.

• Led Verification & Validation, Build & Release Management, and Test Automation for Ophthalmology Imaging products at Forus Health.
• Established and implemented a comprehensive V&V infrastructure, including team formation, process development, competency building, and tool deployment.
• Developed and institutionalized a test automation framework for software verification of releases, ensuring efficient and accurate testing.
• Successfully managed product DMR releases for both installed base and new products, meeting quality and delivery timelines.
• Chaired CCB meetings and coordinated projects for new products and installed base DMR releases, ensuring seamless execution.
• Additionally, oversaw IT and Configuration Management functions, expanding my portfolio.

• Received management appreciation for leading the planning, execution, and qualification of Surround systems testing with EEHR 11.4.1 GA and Hot Fix releases as Interoperability Lead.
• Served as SME for Surround solution modules, including SSMT, Patient Tracking Board, WAND, Allscripts Web Services, MedFlow, and Patient Query, owning complete test accountability.
• Recognized for taking ownership of testing Allscripts Web Services 1.0.4 using SOAP UI, MedFlow 7.6.3, and WAND 1.2 for EEHR 11.4.1 GA release, despite setup challenges.
• Developed hands-on expertise in keyword-driven scripting, contributing 80 automated scripts for EEHR 11.4.1 GA Release.

• Conducted manual and automation testing of Patient Health Record Apps on web and windows platforms, ensuring seamless functionality.
• Verified cross-browser compatibility to guarantee a consistent user experience. Utilized SOAPUI for web services testing, ensuring accurate data exchange.
• Collaborated on multiple products, technologies, and environments, creating high-quality test cases from various sources, including performance use cases, customer use cases, bug fixes, product manuals, customer support tickets, and coverage reports.

• Managed test activities for HIS projects, focusing on technical testing and team development at Napier Healthcare.
• Successfully optimized resources, mitigated risks, and delivered testing activities for KFH Phase 1, LIS, Biomedical Equipment Maintenance, and JDWNRH Phase 1. Defined and delivered BPA test scenarios for JDWNRH release testing, ensuring high-quality results.
• Led the Independent Review team, conducting test reviews for JDWNRH as planned, and ensured timely delivery of high-quality artifacts.
• Provided technical expertise in test development for Biomedical Equipment Maintenance, PACS Integration, and HIS Workflows.

• Managed test planning, execution, and project management for 190Web (Self-care portal) projects, serving the Vodafone Italy account.
• Optimized resources, mitigated risks, and constraints to successfully deliver testing activities for Canvass releases.
• Developed a centralized test status reporting framework across all OBS in the Vodafone-Italy account, earning appreciation from Senior Management.

• Led technical testing of Himalaya software project, Field Service application, and Imaging applications for MR Business unit.
• Received appreciation from Management and onsite partners for proactively driving and implementing FMEA and Test design techniques, enhancing project efficiency.
• Developed and deployed the 'Test System Reservation' tool, enabling project teams to book test systems for testing, and improving resource allocation.
• Received the Spot Award for outstanding efforts in planning and managing test systems and IP Release testing. Consistently achieved a DRE target of 85% on every IP release testing, ensuring high-quality deliverables.
• Proactively initiated and drove TPI activities in the test team, resulting in a successful external audit with 21 Key areas assessed.
• Built and led a high-performing 6-member test team from scratch, focusing on functional and domain competency through targeted ramping and training.

• Led test activities for Image Management platform project, performing hands-on technical testing of various systems, including DPS, C2.1 PACS, Apollo RIS, Centricity Admin tool, C2C, PACS workstation, Seno 2.0 ammography and Crossroads Extends projects.
• Developed automation scripts in Winrunner for DPS regression cases using DFSS methodology, reducing regression test cycle time by 65% as part of the Six Sigma Vitality project
• Received the 'Night on Town Award' twice for exceptional efforts and dedication in driving system validation for Centricity 2.1 PACS and Crossroads Extends at IIS, GE Healthcare.

• Installation, service, maintenance and customer support of manual and fully automated clinical analyzers, including biochemistry, hematology, blood gas analyzers, and glucometers in hospitals.
• Received appreciation from the Zonal Manager for meeting customer expectations in service, customer support, product demonstration, and training.
• Achieved 'Best Performer - Instrument Engineer' award for three consecutive years, recognizing 100% service target achievement and customer confidence in Bayer Diagnostics (I) Ltd.