Hardware Lead
Dozee (company site, opens in a new tab)8+ yrsBengaluruOn-siteDirect career pageEst. 20–35 LPA
Posted 11d ago
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Job description
Structured overview of role & requirements
About This Role
- Lead end-to-end delivery of medical IoT hardware including hardware and firmware from concept through design transfer, ensuring products ship on schedule and to specification.
- Manage and grow a multidisciplinary engineering team across hardware, firmware, and mechanical domains, setting priorities and accountability.
- Own regulatory and compliance activities including risk management, verification planning, and contribution to submissions (FDA 510(k), CE MDR, CDSCO).
Minimum Requirements
- Bachelor's or Master's degree in Electrical, Electronics, Embedded/Computer Engineering or related field.
- 8+ years of hands-on hardware and firmware engineering experience with minimum 2-3 years in a leadership or management role.
- Prior experience in the medical device industry with working knowledge of relevant standards (IEC 60601-1, IEC 62304, ISO 13485, ISO 14971).
- Hands-on experience with risk management (FMEA, hazard analysis) aligned with ISO 14971 and managing hardware/firmware design controls.
Ideal Candidate Profile
- Experienced in delivering complex medical device hardware and firmware from concept through to design transfer and regulatory approval.
- Familiar with coordinating cross-disciplinary engineering teams including mechanical engineering aspects such as enclosure and thermal design.
- Effective in managing timelines and delivering hardware and firmware projects aligned to medical compliance standards and business goals.