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Goutham M

Senior Mechanical Design Engineer | Medical Device NPD (Class B/C) | IEC 60601 | ISO 14971 | V&V | DFM/DFA | Cost Reduction (46%) | Product Lifecycle & Regulatory

Bengaluru

6+ years of work experience

Nesa Medtech
May 20242 yrs 3 mosPresent

Bengaluru, Karnataka, India

Leading end-to-end development of Class B/C medical devices aligned with IEC 60601 standards Owned subsystem design including enclosures, carts, and docking systems Reduced product cost by 46% (₹26K → ₹14K) using DFM optimization Delivered products used in clinical procedures, demos, and trials Executed full Verification & Validation (V&V) and EMI/EMC exposure activities Developed ISO 14971 risk management files including hazard analysis and traceability Contributed to DHF documentation and regulatory readiness (USFDA, CDSCO) Led vendor development across SLA, FDM, machining, and sheet metal Mentored junior engineers and led technical design reviews Key Projects: UTWIN (Class B / Class II) Designed integrated enclosure system with electronics + tablet interface Delivered ~15 units for clinical and commercial use xGEN (Class C / Class II) Developed hybrid enclosure (sheet metal + SLA) Achieved ~₹7K cost reduction per unit.
Helix Private Limited
Jan 20213 yrs 5 mosMay 2024

Bengaluru, Karnataka, India

• Designed oxygen concentrator systems (5 LPM, 10 LPM, wall-mounted) Worked on enclosures using FRP, injection molding, acrylic, and sheet metal Supported product validation, inspection, and manufacturing processes Managed vendors and coordinated production activities Key Projects: Inspiron Series (Class B / Class II) – Portable oxygen systems for medical and home care Wall-mounted Systems – Lightweight, installation-friendly designs OxyPro – Calibration and testing equipment for oxygen delivery systems .My responsibilities In Helix includes designing and developing products that meet the needs of clients and customers. • My work involved utilizing technical skills and knowledge to create detailed designs that met the required specifications. • My contributions in D&D are significant, and for some of the projects, my work was so innovative that my team received a patent. • My experience at Helix Private Limited is giving me a valuable skills in engineering design, project management, and innovation, which can be applied to future roles in the field.
Bharat Electronics Limited
Feb 20191 yr 1 moFeb 2020

Bangalore Urban, Karnataka, India

• Contributed to Software Defined Radio (SDR) systems Designed for high vibration, thermal, and rugged environments Supported validation and testing for defense applications •As a Trainee Engineer at BEL, I worked on various projects for the Indian Army, Navy, and Air force. • My responsibilities included designing and drafting main components, conducting design simulations, and various testing procedures. • I worked under the guidance of my team head to ensure that my work met the required specifications and standards. • My role required attention to details, strong technical skills, and the ability to work collaboratively with other team members. • My experience at BEL has given me a valuable skills in engineering design, testing, and project management, which can be applied to future roles in the field.

Goutham’s AI Stack

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Education

Bachelor of Engineering - BE, Mechanical Engineering

Pesitm

20144 yrs2018

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Goutham M on Tal

Headline

Senior Mechanical Design Engineer | Medical Device NPD (Class B/C) | IEC 60601 | ISO 14971 | V&V | DFM/DFA | Cost Reduction (46%) | Product Lifecycle & Regulatory

About

Senior Mechanical Design Engineer with 6+ years of experience in the medical device domain, specializing in end-to-end product development for regulated markets. I have led the design and development of Class B and Class C medical devices, with strong expertise in IEC 60601 compliance, risk management (ISO 14971), and verification & validation (V&V). My work spans from concept design to product release, including documentation, testing, and clinical readiness. Key highlights: • Delivered multiple medical devices used in clinical procedures and demos • Achieved up to 46% cost reduction through design optimization • Reduced system weight by 35% improving usability and portability • Hands-on experience in EMI/EMC exposure and regulatory-aligned development • Strong ownership of subsystems including enclosures, carts, and docking systems I enjoy solving complex engineering problems, leading design decisions, and working with cross-functional teams to bring high-quality products to market. Currently exploring opportunities with global medical technology organizations where I can contribute to innovative healthcare solutions.

Location

Bengaluru

AI stack

notion

openai

railway

replit

Work experience

Sr. Design Engineer at Nesa Medtech, May 2024 - Present · 2 yrs 3 mos, Bengaluru, Karnataka, India, Leading end-to-end development of Class B/C medical devices aligned with IEC 60601 standards Owned subsystem design including enclosures, carts, and docking systems Reduced product cost by 46% (₹26K → ₹14K) using DFM optimization Delivered products used in clinical procedures, demos, and trials Executed full Verification & Validation (V&V) and EMI/EMC exposure activities Developed ISO 14971 risk management files including hazard analysis and traceability Contributed to DHF documentation and regulatory readiness (USFDA, CDSCO) Led vendor development across SLA, FDM, machining, and sheet metal Mentored junior engineers and led technical design reviews Key Projects: UTWIN (Class B / Class II) Designed integrated enclosure system with electronics + tablet interface Delivered ~15 units for clinical and commercial use xGEN (Class C / Class II) Developed hybrid enclosure (sheet metal + SLA) Achieved ~₹7K cost reduction per unit.

Design Engineer at Helix Private Limited, Jan 2021 - May 2024 · 3 yrs 5 mos, Bengaluru, Karnataka, India, • Designed oxygen concentrator systems (5 LPM, 10 LPM, wall-mounted) Worked on enclosures using FRP, injection molding, acrylic, and sheet metal Supported product validation, inspection, and manufacturing processes Managed vendors and coordinated production activities Key Projects: Inspiron Series (Class B / Class II) – Portable oxygen systems for medical and home care Wall-mounted Systems – Lightweight, installation-friendly designs OxyPro – Calibration and testing equipment for oxygen delivery systems .My responsibilities In Helix includes designing and developing products that meet the needs of clients and customers. • My work involved utilizing technical skills and knowledge to create detailed designs that met the required specifications. • My contributions in D&D are significant, and for some of the projects, my work was so innovative that my team received a patent. • My experience at Helix Private Limited is giving me a valuable skills in engineering design, project management, and innovation, which can be applied to future roles in the field.

Graduate apprentice trainee at Bharat Electronics Limited, Feb 2019 - Feb 2020 · 1 yr 1 mo, Bangalore Urban, Karnataka, India, • Contributed to Software Defined Radio (SDR) systems Designed for high vibration, thermal, and rugged environments Supported validation and testing for defense applications •As a Trainee Engineer at BEL, I worked on various projects for the Indian Army, Navy, and Air force. • My responsibilities included designing and drafting main components, conducting design simulations, and various testing procedures. • I worked under the guidance of my team head to ensure that my work met the required specifications and standards. • My role required attention to details, strong technical skills, and the ability to work collaboratively with other team members. • My experience at BEL has given me a valuable skills in engineering design, testing, and project management, which can be applied to future roles in the field.

Education

Bachelor of Engineering - BE, Mechanical Engineering, Pesitm