Bharath Shekar

Senior Mechanical Design Engineer

Stryker Global Tech Center

10.2020 - Current

Design, Develop, Modify and Verify mechanical components for new medical devices along with aggressive prototyping (Design & Manufacturing) for neurosurgical research projects and to optimize existing products.
Collaborated with cross-functional teams to develop innovative solutions for product enhancements.
Coordinated project schedules, resources, and communication among stakeholders to enhance collaboration.
Led cross-functional teams to ensure project deliverables met timelines and quality standards. Executing NPD projects involving the complete product development life cycle phases from concept to launch.
Executing technical and multi-functional design verification and design validation activities. Generation of development tests, verification tests protocols to test and to validate the functional life, characteristics, simulated use cases of the components.
Test fixture design to support the components during the testing for various testable & measurable parameters.
Creation or remediation of Design History Files, Device Master Records, and other related technical documents including drawings, labeling, packaging, instructions for use, etc.
Liaison with the lab team to carry out verification and validation activities that include the development of test methods, test protocols, test method validation, test execution, analysis, and reporting.
Real-time application of the designed devices through Cadaver lab visits and understanding the user needs for new devices from surgeons at VOC events.
Application of Stryker design controls for a structured, phase-gated (stage-gated) new product development process.
Working on multiple projects simultaneously in product engineering such as gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc.
Risk analysis and DFMECA during development phase of the component, create components and prints as per ASME standards. Work with supplier for on time delivery of design tangibles for OEM products.
Travel to Cork, Ireland (Sep 2023) for V&V testing activities and Kalamazoo, USA (Mar 2025) for prototyping & AANS lab . Continuous collaboration with global stakeholders (US, Freiburg, Cork).