Ashwani Bonthu,PMP, CSM, SAFe® 6 Agilist, SM,Six Sigma

. Managing the development of a voice-enabled, AI-driven report automation system. · Integrating flexible input modes, image workflows, and customizable templates. · Automated capture of critical quality metrics, reducing manual input and ensuring accurate, real-time reporting. · Development of IFUs, ensuring global regulatory compliance across all digital workflows.

Clients: Vision Service Plan, FullSpectrum, Wayfair

· Planning, directing, and implementing a Class III medical device program from introducing Agile processes, identification of teams to FDA approval. · Leading comprehensive critical path analysis, simulation, scenario planning for Pre-Pivotal submission.

· Enabled effective strategic, operational planning and decision making for FDA submission. · Maintaining high-level integrated project plan, with input from all key stakeholders/functions, and ensuring progress against all workstreams. · Partnering with functional leaders, vendors, and contractors to define project strategies and escalate risks, gaps and challenges, key dependencies and decisions points. · Implementing Scrum and Waterfall based on the team size and product platform. · Worked with Engineering, Software, UI, QA, Regulatory, Product Management, and Business; to provide more transparency across the 7 departments; and to obtain great business value with short turnarounds.

• Maintained a library of configuration files that are required for the successful installation of image management products. • Developed reports for management to determine short comings in the product. • Developed and maintained processes and procedures for customer site pre-assessment data, translating gathered data into installation plan and establishing cloud credentials for Image Management Product. • Sole point of contact for install team and support team during Image Management Product deployment until project go-live. • Developed and conducted integration-related trainings for support staff. • Interfaced with third party EHR to facilitate integration with diagnostic imaging and image management products (with Optos applications). • Worked on DICOM interfaces and command line interfaces. • Trained staff and maintain documentation for EMR interface. . Applied lean methodologies to optimize medical device development processes, reducing resource use and supporting corporate sustainability objectives

• Led multiple Healthcare IT projects to ensure successful completion of every step of SDLC • Managed go-live activities. • Analyzed customer requirements and translated them into information requirements for HL7, C32 and xml standard formats. • Collaborated with development and support teams leading to successful deliveries of multiple projects ensuring customer satisfaction. • Ensured success in conversion testing efforts and quality review on all interface processes. • Worked with middleware’s and interfaced with state immunization registries. • Knowledge in Meaningful use.