Roles and Responsibilities:

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

Create schematics, PCB layouts, and hardware architecture in compliance with product requirements.

Select and qualify components considering performance, reliability, and regulatory constraints.

Collaborate with mechanical and software teams to ensure seamless system integration.

Develop and execute hardware verification plans including functional, electrical safety, EMC, and

environmental testing.

Support design verification and validation activities in alignment with IEC 60601 and ISO 80601

standards.

Troubleshoot and debug hardware issues during development and testing phases.

Document test procedures, results, and compliance evidence for regulatory submissions.

Ensure hardware design complies with - IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC), ISO

13485 (Quality Management Systems), FDA 21 CFR Part 820.30 (Design Controls)

Collaborate with manufacturing and supply chain teams for design transfer and production readiness.

Support DFM (Design for Manufacturability) and DFA (Design for Assembly) initiatives.

Proficient in hardware and simulation tools.

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

Work closely with systems, software, mechanical, and quality teams to ensure hardware meets

system-level requirements.

Education & Skills preferred:

MTech / ME / BE / BTech in Electrical Engineering, Electronics, Biomedical Engineering, or related

field.

3-9 years of experience in hardware design for medical devices

Experience with ventilators, CPAP, BiPAP, or similar life-support systems is highly preferred.

Strong understanding of medical device lifecycle, design controls, and regulatory frameworks

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

Certification in hardware design, medical electronics, or quality systems is desirable.

Strong analytical, documentation, and communication skills.

Hardware Design Engineer