Hardware Engineer - Medical Device

Job Description - Hardware Engineer (Medical Devices)

Role: Hardware Engineer
Experience: 4-5 Years
Location: Bangalore / Pune (Onsite)
Industry: Medical Devices / Healthcare Technology

Role Overview

We are seeking an experienced Hardware Engineer

s and ensuring compliance with international medical device standards.

Roles & Responsibilities

• Design and develop analog and digital hardware for electromechanical medical devices.

• Ensure hardware designs comply with IEC 60601-1 (General Safety) , IEC 60601-1-2 (EMC) , and ISO 13485 (QMS) requirements.

• Create Hardware Requirement Specifications (HRS) aligned with system and product requirements.

• Develop schematics and hardware architecture using Altium Designer .

• Possess working knowledge of PCB layout design and collaborate closely with layout engineers.

• Develop and execute hardware verification and validation plans , including:

  • Functional testing

  • Electrical safety testing

  • EMC testing

  • Environmental testing

• Support Design Verification & Validation (DV&V) activities in compliance with IEC 60601 and ISO 80601 standards.

• Select and qualify electronic components considering performance, reliability, availability, and regulatory constraints .

• Prepare and maintain test procedures, reports, and compliance documentation for EU MDR submissions.

• Collaborate with manufacturing and supply chain teams to support design transfer and production readiness.

• Participate in DFMEA , DFM (Design for Manufacturability) , and DFA (Design for Assembly) activities.

• Maintain complete hardware documentation including schematics, BOMs, test reports, and change records .

• Work closely with systems, software, mechanical, and quality teams to ensure system-level integration and compliance.

Education & Skills

Education

• BE / BTech / ME / MTech in Electronics, Biomedical Engineering , or a related discipline.

Experience

• 4-5 years of hands-on experience in hardware design for medical devices or other regulated industries.

Technical Skills

• Strong knowledge of medical device lifecycle and design controls .

• Familiarity with EMC testing , electrical safety standards , and component reliability analysis .

• Experience with Altium Designer for schematic capture and PCB-related activities.

• Understanding of regulatory frameworks such as IEC 60601 , ISO 13485 , and ISO 80601 .