Risk Manager & Systems Designer - Medical devices

India

Kochi, Kerala, India

Bangalore Urban, Karnataka, India

Chennai, Tamil Nadu, India

San Diego County, California, United States

India

Chennai Area, India

Chennai Area, India

Bachelor of Technology (B.Tech.), Mechanical Engineering
Dr M G R Educational and Research Institute

Computer Science
Bala Vidya Mandir
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Pragmatist Multi Disciplinary Engineer in Medical Devices Domain. individual contributor for electro mechanical Systems engineering, Sustenance engineering, Design control, Electro-Mechanical Product Design, QMS,IVD's, SAMD, Disposables and Engineering Change process(ECR&ECN). Started career in Design & Development and Sustenance engineering on Surgical Robotics for Interventional Oncology. Transitioned to Verification and Validation for Rapid Diagnostics, Biologics & IVD. Currently system design owner for class 2 electro mechanical NPD Medical Device. Actively practice MBSE, FMEA, PMP, TRIZ and DMAIC. Proficient in 13485, 14971, 60601, 10993, 62304, 62366 and other medical related ISO, IEC, ETSI, ISED and ASTM Standards. Highly exposed and skilled on Compliance, Development and Remediation activities for FDA, MDSAP, CFDA, MDD, MDR and IVDR. Auditee for Design and Development during NB audits. Passionate on solving complex problems to improve the quality of life of people.
Pune District
claude code
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Bachelor of Technology (B.Tech.), Mechanical Engineering, Dr M G R Educational and Research Institute
Computer Science, Bala Vidya Mandir