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Mahesh Gonal

Head of R&D | Medical Device Product Development | Surgical Visualization | Arthroscopy | Engineering Leadership | Product Strategy | ISO 13485 | FDA | EU MDR | Cross-Functional Leadership

Greater Bengaluru Area

16+ years of work experience

Sironix Medtech
Jul 20224 yrs 4 mosPresent

Bengaluru

Lead multidisciplinary R&D teams across Mechanical, Electronics, Software, QA, Regulatory and Manufacturing. Define product roadmap for Arthroscopy and Surgical Visualization platforms. Own complete product lifecycle from concept through commercialization. Manage supplier development and global technology partnerships. Drive regulatory compliance with ISO 13485, IEC 60601, ISO 14971, FDA Design Controls and EU MDR. Led development of multiple active medical device platforms. Managed multi-crore R&D investment planning. Built cross-functional engineering teams. Reduced development cycle through structured project management. Improved product quality through Design Reviews, FMEA and Risk Management.
Akna Medical Pvt Ltd (Aknamed)
Jul 20202 yrsJun 2022

Bengaluru, Karnataka, India

Sep 20181 yr 10 mosJun 2020

Bangalore

Healthium Medtech Pvt. Ltd.
Apr 20162 yrs 5 mosAug 2018

Bangalore

SIRONIX Arthroscopy
Healthium Medtech Pvt. Ltd.
Apr 20124 yrsMar 2016

Bangalore, India

Healthium Medtech Pvt. Ltd.
May 201111 mosMar 2012

Bangalore

Tiens Corp.Inc.
Feb 20091 yr 10 mosNov 2010

Bangalore

Mahesh’s AI Stack

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Education

Indian Institute of Management, Kozhikode

eMDP General Management- GMP, Marketing/Marketing Management, General

Indian Institute of Management, Kozhikode

20211 yr2022
MICA | The School of Ideas

PGDM, Business, Management, Marketing

MICA | The School of Ideas

20161 yr2017

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Headline

Head of R&D | Medical Device Product Development | Surgical Visualization | Arthroscopy | Engineering Leadership | Product Strategy | ISO 13485 | FDA | EU MDR | Cross-Functional Leadership

About

I am a Medical Device Product Development Leader with over 18 years of experience leading the design, development, verification, validation, and commercialization of innovative medical technologies. Throughout my career, I have successfully built multidisciplinary engineering teams and delivered products across Surgical Visualization, Arthroscopy, Active Medical Devices, Implants, and Electrosurgical Systems. My expertise spans the complete product lifecycle—from Voice of Customer and concept generation to design, regulatory compliance, manufacturing transfer, and commercial launch. I currently lead New Product Development initiatives involving: ✔ Surgical Camera Systems (HD & 4K) ✔ Arthroscopy Systems ✔ RF Electrosurgical Systems ✔ Arthro Pumps & Fluid Management ✔ Shaver Systems & Power Tools ✔ Medical Implants My strengths include: • New Product Development (NPD) • Engineering Leadership • Product Strategy • Design Controls • ISO 13485 • FDA Design Controls • EU MDR • Risk Management (ISO 14971) • Cross-functional Leadership • Supplier Development • Design Verification & Validation • CAPEX Planning • Product Lifecycle Management

Location

Greater Bengaluru Area

AI stack

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openai

ChatGPT

Work experience

Head NPD SIRONIX Arthroscopy - Medical Devices at Sironix Medtech, Jul 2022 - Present · 4 yrs 4 mos, Bengaluru, Lead multidisciplinary R&D teams across Mechanical, Electronics, Software, QA, Regulatory and Manufacturing. Define product roadmap for Arthroscopy and Surgical Visualization platforms. Own complete product lifecycle from concept through commercialization. Manage supplier development and global technology partnerships. Drive regulatory compliance with ISO 13485, IEC 60601, ISO 14971, FDA Design Controls and EU MDR. Led development of multiple active medical device platforms. Managed multi-crore R&D investment planning. Built cross-functional engineering teams. Reduced development cycle through structured project management. Improved product quality through Design Reviews, FMEA and Risk Management.

Vice President- Private Label at Akna Medical Pvt Ltd (Aknamed), Jul 2020 - Jun 2022 · 2 yrs, Bengaluru, Karnataka, India

Senior Marketing Manager at Investribe, Sep 2018 - Jun 2020 · 1 yr 10 mos, Bangalore

Product Manager Arthroscopy at Healthium Medtech Pvt. Ltd., Apr 2016 - Aug 2018 · 2 yrs 5 mos, Bangalore, SIRONIX Arthroscopy

Assistant Manager at Healthium Medtech Pvt. Ltd., Apr 2012 - Mar 2016 · 4 yrs, Bangalore, India

Senior Officer PMT at Healthium Medtech Pvt. Ltd., May 2011 - Mar 2012 · 11 mos, Bangalore

Product Trainer at Tiens Corp.Inc., Feb 2009 - Nov 2010 · 1 yr 10 mos, Bangalore

Education

eMDP General Management- GMP, Marketing/Marketing Management, General, Indian Institute of Management, Kozhikode

PGDM, Business, Management, Marketing, MICA | The School of Ideas

Mahesh Gonal - Head NPD SIRONIX Arthroscopy - Medical Devices in Greater Bengaluru Area | Tal