Lead Software Engineer

PURPOSE AND SCOPE

The Lead Software Engineer owns the system architecture for the software and firmware that make up the Company's medical electronic device products, including embedded firmware for connected/wearable devices and companion mobile applications (Software as a Medical Device, SaMD). This role provides technical leadership across the software engineering team, ensuring architectural coherence, code quality, and design robustness from concept through production.

As the software engineering team grows, this role is expected to provide technical direction and day-to-day guidance to software engineers reporting into the position.

ROLES & RESPONSIBILITIES

● Define and own the software/firmware system architecture spanning the wearable sensor/transmitter firmware and the companion mobile application.

● Lead architectural design decisions, including module decomposition, communication protocols (e.g., BLE), data flow, and interfaces between firmware, mobile app, and cloud.

● Drive technical design reviews and ensure the architecture aligns with product requirements, performance targets, and software lifecycle standards (IEC 62304).

● Contribute hands-on development of critical firmware and/or mobile application components as needed.

● Establish coding standards, design patterns, and software development best practices across firmware and mobile codebases.

● Collaborate with Systems Engineering, Quality, and Regulatory Affairs to ensure the software architecture supports risk management (ISO 14971) and traceability requirements.

● Guide technology selection (RTOS, communication stacks, mobile frameworks), balancing performance, power, security, and maintainability.

● Support software risk analysis and participate in software FMEA/hazard analysis activities.

● Own the software configuration management strategy, branching model, and release process across firmware and mobile codebases.

● Provide technical mentorship and code review guidance to software engineers; as the team grows, will directly guide software engineers reporting into this role.

● Partner with Product Management and Systems Engineering to translate product requirements into software architecture and implementation plans.

● Support software verification and defect resolution for architecture-level issues.

● Apply working knowledge of FDA premarket cybersecurity requirements and guidance to inform software and hardware architecture decisions that reduce risk and help streamline regulatory registration.

QUALIFICATIONS AND EXPERIENCE
● Minimum 8–10 years of software/firmware engineering experience, with at least 3 years in a technical leadership or architecture role.

● Proven experience architecting embedded firmware for connected or wearable medical or consumer electronic devices.

● Proven experience architecting or leading development of mobile applications (iOS and/or Android), ideally within a SaMD or other regulated software context.

● Strong understanding of embedded systems, RTOS, low-power design, and wireless communication protocols (BLE/Bluetooth).

● Strong understanding of mobile application architecture patterns and secure cloud connectivity.

● Working knowledge of IEC 62304, ISO 14971, IEC 62366-1, and FDA/EU MDR software expectations.

● Experience with software configuration management, CI/CD pipelines, and code review practices.

● Prior experience mentoring or leading engineers, even informally, preferred.

● Bilingual proficiency in English and Chinese (spoken and written), with the ability to communicate and produce technical documentation in both languages — English to support FDA and EU MDR regulatory submissions, and Chinese to support NMPA registration submissions for the Chinese market.

● Working knowledge of FDA premarket cybersecurity guidance and expectations (e.g., secure design principles, software bill of materials (SBOM), vulnerability management) as applied to connected medical devices.