BHARATH
Senior Mechanical Design Engineer
MaleMechanical product planningLive in ShanghaiNationality
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Work experience
Senior Mechanical Design Engineer
Stryker Global Tech Center india2020.10-Current(6 years)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. • Project management for schedules, resources, and communication among stakeholders to enhance collaboration. • Conducted user-centered design research through direct surgeon engagement at VOC events and cadaver labs, translating clinical user needs and workflow observations into actionable design requirements for neurosurgical devices. • Performed use-related risk assessments integrating human factors considerations into DFMECA analysis, identifying and mitigating potential use errors and hazardous situations throughout product development lifecycle. • Executed formative usability evaluations through iterative prototyping and simulated use testing with clinical stakeholders, incorporating user feedback to optimize device ergonomics, intuitiveness, and safe use. • Developed and executed verification and validation protocols incorporating human factors testing methodologies, including task analysis, use scenario validation, and clinical simulated use testing in cadaver lab environments. • Designed test fixtures and simulated use environments to replicate real-world clinical conditions for usability validation and use error identification • Records, and other related technical documents including drawings, labeling, packaging, instructions for use, etc. • Development of test methods, test protocols, test execution, analysis, and reporting for development & verification testing. • Observational research through Cadaver lab to understand real- world device usage patterns and work flow integration. • Application of Stryker design controls for a structured, phase-gated (stage-gated) new product development process. • Collaboration with vendors for PPAP requirements, process development, schedule and manufacturing planTransaction Risk Investigator
Amazon2017.09-2018.12(a year)• Risk management and quality maintenance tools application to understand customer needs and ensure hassle-free and safe business operations.
Educational experience
Vellore Institute of Technology
M.TECH Computer Aided Design and Manufacturing2017.09-2021.09(4 years)
Certificates
TUV SUV Lean 6 Sigma Green Belt
Certified
• TUV SUD Internal Auditor TP on
Medical Devices - QMS based on ISO
13485:2016
• Goethe Institute - German A2
•CSWA Solidworks(full exam)
•HYPERMESH based ABAQUS
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