Saurabh Pande (AMIE) on Tal
Headline
Head of Medical Product Development| ISO/IEC 13485:2016 & ISO/IEC 27001:2022 Internal Auditor | DPDP Act 2023 Practitioner | NPI/NPD | Medical Devices & Regulatory | Hardware Designer & Architect | Building AyuSynk
About
Highly skilled and results-driven professional in Product Development and Production, with over 7+ years of experience in the medical devices industry, specializing in hardware design, ISO 13485 compliance, ISO 27001, IEC safety standards (e.g., IEC 60601, IEC 62304), EMI/EMC compliance, and production workflow optimization. Successfully led 10+ cross-functional projects, bringing 5+ medical devices from concept to market. Proven ability to reduce production cycle time, improve yield, and ensure 100% adherence to regulatory and quality standards. Core competencies include: Hardware Design & Development: Specialized in circuit design, schematic capture, PCB layout, and DFM/DFT practices for medical-grade electronics. Regulatory Compliance: Deep expertise in ISO 13485, IEC 60601, and EMI/EMC testing and certification. SAMD (Software as a Medical Device): Oversaw development and risk management SAMD-based systems (IEC 62304). Product & Market Analysis: Conducted successful product-market fit assessments, resulting in faster go-to-market strategy. Production Excellence: Managed teams of up to 15+ engineers and technicians, optimizing workflows and implementing Lean principles. Quality & Internal Audits: Executed multiple internal audits and Managed QMS system. Passionate about leveraging technology to improve healthcare, I am committed to innovation, regulatory excellence, and building life-enhancing products that positively impact society.
Work experience
Head of Product Development and Production at AyuSynk.ai, Nov 2023 - Present · 2 yrs 10 mos, Bengaluru, Karnataka, India
Sr. Hardware Design and Procurement Engineer at AyuSynk.ai, Jan 2022 - Nov 2023 · 1 yr 11 mos, Mumbai, Maharashtra, India, Ayu Devices is an Startup Medical Product firm spun out of BETIC, IIT BOMBAY and is supported by BIRAC, DBT- Government Of India.
PCB Design, Hardware Developer and Procurement Engineer at AyuSynk.ai, Jan 2021 - Jan 2022 · 1 yr 1 mo, Mumbai, Maharashtra, India, Ayu Devices Pvt Ltd. Ayu Devices is a technology-based healthcare company spun out of BETiC, IIT Bombay
Jr. Embedded Engineer at Technokeens, Mar 2018 - Sep 2018 · 7 mos, Nashik
Education
Master of Technology - MTech, Electronic Design and Technology, NATIONAL INSTITUTE OF ELECTRONICS & INFORMATION TECHNOLOGY (NIELIT)
PD503: Certificate Course on Electronics Board design and Bring up, Electrical, Electronics and Communications Engineering, NATIONAL INSTITUTE OF ELECTRONICS & INFORMATION TECHNOLOGY (NIELIT)
