Hardware Lead

The Hardware Team Lead owns end-to-end delivery of Dozee's medical IoT hardware, from concept through design transfer. This person leads a cross-disciplinary team spanning hardware, firmware, and mechanical engineering, and is accountable for shipping products on schedule, to spec, and in line with the regulatory and compliance standards required of medical devices.

Key Responsibilities

• Lead, mentor, and grow a team of hardware, firmware, and mechanical engineers, setting priorities and holding the team accountable for output.
• Own product delivery end to end: translate product requirements into engineering plans, track milestones, and ensure devices ship on schedule and to spec.
• Drive hardware and firmware architecture and design for Dozee's contactless RPM devices, from concept and prototyping through verification - scope of ownership runs through design transfer.
• Guide firmware development choices - embedded/RTOS architecture, driver design, and hardware-firmware integration - working closely with firmware engineers even where they own day-to-day implementation.
• Build and test functional prototypes at each design stage to validate performance before moving to verification.
• Plan and oversee compliance testing (EMC, electrical safety, environmental, biocompatibility where applicable) so designs meet IEC and ISO standards before submission.
• Own the hardware and firmware contribution to regulatory submissions and technical documentation (FDA 510(k), CE MDR, CDSCO) in partnership with the regulatory affairs team.
• Own risk management across hardware and firmware: maintain risk files, run hazard/FMEA analyses, and drive mitigations in line with ISO 14971.
• Triage and resolve field complaints and hardware/firmware-related support tickets, driving root-cause analysis and corrective/preventive action (CAPA).
• Work cross-functionally with product management, quality, supply chain, and software teams to align hardware plans with business goals.
• Report progress, risks, and resourcing needs to leadership.

Required Qualifications & Experience

• Bachelor's or Master's degree in Electrical, Electronics, Embedded/Computer Engineering (or a related field).
• 8+ years of hands-on hardware and firmware engineering experience, with at least 2-3 years leading or managing an engineering team.
• Prior experience in the medical device industry is required - familiarity with how design controls, risk management, and regulatory submissions shape hardware and firmware decisions.
• Well-versed in firmware development and architecture - embedded/RTOS or bare-metal firmware, driver design, and hardware-firmware integration
• Track record of taking hardware and firmware together from concept through prototyping, verification, and design transfer.
• Hands-on experience running or overseeing risk management activities (FMEA, hazard analysis) in line with ISO 14971.
• Experience coordinating mechanical engineering work streams (enclosure, thermal, DFM) alongside electrical and firmware scope.
• Comfortable owning delivery timelines and communicating trade-offs to product and leadership stakeholders.

Regulatory & Compliance Knowledge

• Working knowledge of IEC 60601-1 (general safety and essential performance) and its collateral standards, such as IEC 60601-1-2 (EMC).
• Working knowledge of IEC 62304 (software lifecycle for medical devices) - directly relevant given this role's ownership of firmware architecture, not just electrical/PCB design.
• Understanding of ISO 13485 (quality management systems) and ISO 14971 (risk management) and how they shape hardware design decisions.
• Exposure to IEC 61010 (safety for lab/test equipment) and other bench-testing standards where relevant to the product line.
• Familiarity with how compliance testing (EMC/EMI, electrical safety, environmental, biocompatibility) is planned and executed with test labs and certification bodies.
• Working knowledge of the regulatory pathways Dozee operates under: FDA 510(k), CE MDR, and CDSCO, and how hardware documentation feeds into these submissions.

Preferred / Nice-to-Have Qualifications

• Experience with contactless or wearable vital-signs monitoring hardware (PPG, ECG, or similar sensing modalities).
• Prior experience scaling a hardware / firmware team in a startup or fast-growing company.
• Experience with RTOS-based or bare-metal firmware architectures (FreeRTOS, Zephyr, or similar) for battery-powered, connected medical/IoT devices.
• Hands-on experience with PCB design tools (Altium, Cadence, or similar) and EMI/EMC troubleshooting.
• Exposure to connected/IoT device architectures (BLE, Wi-Fi, cellular) and cloud-connected fleets.