Uma Gokhale
Senior Software Quality Assurance Engineer @Veranex
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WORK HISTORY
Senior Software Quality Assurance Engineer @Veranex
Orange, CA, US
Collaborated cross-functionally with SMEs, MEs, EEs, DA engineers, and clients to support full lifecycle product development. Helped define and implement the internal process for software maintenance, including documentation standards, patch/update procedures, and regression testing protocols. Executed and documented development activities such as requirements analysis, use case development, and risk management to support full V&V compliance. Led device design and change control processes, collaborating with clients to meet design control timelines and regulatory requirements. Supported software testing and traceability to ensure post-change compliance with internal quality systems and external regulations. Developed software requirements for OTS/SOUP and cybersecurity documentation, ensuring full regulatory and quality system alignment. Authored cybersecurity deliverables and templates for cross-functional use, promoting consistency and compliance across projects. Led organization-wide cybersecurity, IEC 62304, The Role of a SQA trainings, and various other study group session trainings to promote secure development practices. Participated in project estimation to integrate quality and compliance considerations into planning and resource allocation. Supported CAPA resolution by updating Quality System Procedures (QSPs), enhancing compliance and audit readiness.
EDUCATION
The University of Akron
Bachelor of Science - BS, Biomedical Engineering - Biomechanics
The University of Georgia
Master of Science - MS, Kinesiology - Exercise Physiology (Thesis)
ABOUT UMA GOKHALE
Hi, I’m Uma, a Subject Matter Expert in Software as a Medical Device (SaMD) with 8+ years of experience driving quality and compliance in the development of innovative medical technologies. I specialize in leading cross-functional teams and crafting robust testing strategies for software-based medical devices, including those incorporating Artificial Intelligence (AI) and advanced Cybersecurity measures.My expertise lies in navigating complex regulatory landscapes, including FDA and ISO standards, to ensure that SaMD products are not only compliant but also high-performing and user-centric. I’ve led initiatives across diverse therapeutic areas, ranging from neurological disorders and cardiovascular health to athletics and military medicine, bringing a deep understanding of clinical and technical requirements to every project. I’ve had the opportunity to contribute in both agile startup environments and large-scale engineering product development firms, giving me a unique perspective on scaling quality systems and adapting best practices to different organizational needsI have always played a key role in shaping software verification processes, aligning design inputs with regulatory expectations, and mentoring teams on several relevant standards. I thrive in collaborative, fast-paced environments where quality, innovation, and patient safety intersect.Let’s connect—I’m always open to conversations about advancing healthcare through smarter, safer software.
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