Hardware Design Engineer

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.