Hardware Lead

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).

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.

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.