About

Hemant Pundpal is a highly experienced Principal Engineer in medical device and software development with over 20 years of experience. He has a strong product thinking ability and a broad vision of multi-generation product development. Hemant is skilled in analyzing "intended use" and "defined user needs" to define product feature roadmaps. He is an expert in defining and driving product features roadmap in incremental product program releases with cross-functional development teams and scrum teams. Hemant has extensive experience in agile product development processes, including backlog grooming, sprint planning, and retrospective, and he can lead a scrum team. He has expertise in all stages of product development life cycle, from customer input, concept, design input, design output, design verification & validation, design change, design transfer, complaint management (CAPA) and continuous support. Hemant is a strong influential leader with product engineering experience to work with cross-functional teams. Hemant has led medical device product development for major features like Image Acquisition workflow application, client server-based DICOM and service applications, Motion Control (Patient Positioning) application, X-Ray Generator application for a variety of successful products of GE, Philips, and SAMSUNG. He is experienced in hiring, coaching, and mentoring software development teams. Hemant is an expert in Software Architecture, Design Patterns, Usability, and Embedded Systems. He is knowledgeable in medical device regulation compliance and approval for FDA, CE, TGA, and MEDSAFE. Hemant has worked with standards such as Software (IEC 62304, AAMI TIR45), Risk Assessment (ISO 14971), Usability (IEC 62366), Cybersecurity (AAMI TIR57); Basic safety and essential performance (IEC 60601-1), Electromagnetic disturbances (IEC 60601-1-2), home health environment (IEC 60601-1-11), quality management system ISO 13485, and regulations such as 21 CFR, Chapter 1, Subchapter H – Medical Devices; MDD 93/42/EEC and good understanding of MDR 2017/745; TGA - Therapeutic Goods (Medical Devices) Regulations 2002; MEDSAFE - Medicines (Database of Medical Devices) Regulations 2003. Hemant has a Bachelor of Engineering degree in Electronics and Telecommunication from s. s. jondhale coe and a Diploma in Industrial Electronics from ny