Hardware Engineer Medical Device
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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
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Design and develop analog and digital hardware for electromechanical medical devices.
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Ensure hardware designs comply with IEC 60601-1 (General Safety) IEC(EMC) and ISO 13485 (QMS) requirements.
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Create Hardware Requirement Specifications (HRS) aligned with system and product requirements.
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Develop schematics and hardware architecture using Altium Designer.
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Possess working knowledge of PCB layout design and collaborate closely with layout engineers.
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Develop and execute hardware verification and validation plans including:
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Functional testing
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Electrical safety testing
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EMC testing
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Environmental testing
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Support Design Verification & Validation (DV&V) activities in compliance with IEC 60601 and ISO 80601 standards.
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Select and qualify electronic components considering performance reliability availability and regulatory constraints.
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Prepare and maintain test procedures reports and compliance documentation for EU MDR submissions.
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Collaborate with manufacturing and supply chain teams to support design transfer and production readiness.
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Participate in DFMEA DFM (Design for Manufacturability) and DFA (Design for Assembly) activities.
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Maintain complete hardware documentation including schematics BOMs test reports and change records.
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Work closely with systems software mechanical and quality teams to ensure system-level integration and compliance.
Education & Skills
Education
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BE / BTech / ME / MTech in Electronics Biomedical Engineering or a related discipline.
Experience
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4-5 years of hands-on experience in hardware design for medical devices or other regulated industries.
Technical Skills
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Strong knowledge of medical device lifecycle and design controls.
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Familiarity with EMC testing electrical safety standards and component reliability analysis.
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Experience with Altium Designer for schematic capture and PCB-related activities.
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Understanding of regulatory frameworks such as IEC 60601 ISO 13485 and ISO 80601.
Required Skills:
Medical DevicesPCB Designpcb layoutIEC 60601ISO 80601
Key Skills
- Arm
- Electrical Engineering
- SOC
- System Design
- Firmware
- C/C++
- PCB
- Sensors
- Fpga
- Digital design
- Assembly
- Product Development
