Hardware Engineer

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.Qualifications- MTech / ME / BE / BTech in Electrical Engineering, Electronics, Biomedical Engineering, or related field.Required Skills- 3-6 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.Preferred SkillsThe profile requires*Designing & Developing analog and digital hardware components for electro mechanical medical devices.Pay range and compensation packageOffered CTC upto 27LPAJob Location: PuneLooking for immediate to 45 days notice period.

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