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Deebavignesh Subash

Risk Manager & Systems Designer - Medical devices

Pune District

9+ years of work experience

Dräger
May 20251 yr 3 mosPresent

India

Zealogics Inc
Jul 20222 yrs 11 mosMay 2025

Kochi, Kerala, India

Medtronic
Jul 20222 yrs 11 mosMay 2025

Bangalore Urban, Karnataka, India

HCL Engineering and R&D Services
Jul 20211 yr 1 moJul 2022

Chennai, Tamil Nadu, India

HCL Engineering and R&D Services
Oct 20219 mosJun 2022

San Diego County, California, United States

Verification & Validation - Systems, Software, Equipments, Utilities, Facilities and TMV
PERFINT HEALTHCARE Pvt Ltd.
Apr 20214 mosJul 2021

India

PERFINT HEALTHCARE Pvt Ltd.
Aug 20182 yrs 9 mosApr 2021

Chennai Area, India

PERFINT HEALTHCARE Pvt Ltd.
Jul 20171 yr 2 mosAug 2018

Chennai Area, India

Deebavignesh’s AI Stack

claude code
claude code

Education

Bachelor of Technology (B.Tech.), Mechanical Engineering

Dr M G R Educational and Research Institute

20134 yrs2017
Bala Vidya Mandir

Computer Science

Bala Vidya Mandir

200013 yrs2013

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Headline

Risk Manager & Systems Designer - Medical devices

About

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.

Location

Pune District

AI stack

claude code

Work experience

System Designer at Dräger, May 2025 - Present · 1 yr 3 mos, India

Requirements Management Engineer at Zealogics Inc, Jul 2022 - May 2025 · 2 yrs 11 mos, Kochi, Kerala, India

System Engineer at Medtronic, Jul 2022 - May 2025 · 2 yrs 11 mos, Bangalore Urban, Karnataka, India

Lead Engineer at HCL Engineering and R&D Services, Jul 2021 - Jul 2022 · 1 yr 1 mo, Chennai, Tamil Nadu, India

Abbott - Rapid Diagnostics and Biologics at HCL Engineering and R&D Services, Oct 2021 - Jun 2022 · 9 mos, San Diego County, California, United States, Verification & Validation - Systems, Software, Equipments, Utilities, Facilities and TMV

Senior Engineer-Design at PERFINT HEALTHCARE Pvt Ltd., Apr 2021 - Jul 2021 · 4 mos, India

ENGINEER DESIGN at PERFINT HEALTHCARE Pvt Ltd., Aug 2018 - Apr 2021 · 2 yrs 9 mos, Chennai Area, India

Trainee - Design Engineer Mechanical at PERFINT HEALTHCARE Pvt Ltd., Jul 2017 - Aug 2018 · 1 yr 2 mos, Chennai Area, India

Education

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

Computer Science, Bala Vidya Mandir

Deebavignesh Subash - System Designer in Pune District | Tal