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.

Skills Required