Lead Systems Engineer

Position Overview

We are seeking a talented and motivated Senior Embedded Systems Engineer to join our team full-time at our Bay Area facility. This is an on-site position offering hands‑on experience with cutting‑edge medical device technology.

In this role, you will lead the development of the uLink external console as we prepare for design freeze, OUS regulatory submission and first‑in‑human clinical deployment. You'll take technical ownership of the device's critical sub‑system while collaborating with our multidisciplinary engineering team to deliver a safe and reliable external device.

The ideal candidate thrives in dynamic startup environments, brings strong organizational and technical skills combined with a collaborative mindset, and is excited by the opportunity to make meaningful contributions to a product that will directly impact patient lives. This position offers the chance to shape the future of our technology and organization for the right individual.

• Drive the uLink external console from advanced prototype through design verification and OUS regulatory submission to first‑in‑human clinical trials
• Work with external service providers to manage electrical and mechanical component supply, device builds, testing and inspections
• Own verification and validation (V&V) activities including managing external testing services for console related tests (Electrical Safety Testing, EMC Testing, etc.)
• Ensure compliance with applicable regulatory standards (IEC 60601, etc.) and internal quality requirements
• Lead technical troubleshooting and implement innovative solutions to enhance device performance, reliability, patient safety and manufacturability
• Establish and maintain rigorous design documentation and traceability within the company's Quality Management System
• Draft test protocols and reports for various console related DV and characterization tests
• Contribute to cross‑functional design reviews and risk assessments to drive product maturation toward clinical milestones

• B.S. in Electrical Engineering, Computer Engineering, or related technical field
• Proven track record developing electronic embedded systems for medical devices
• 5+ years in medical device development with demonstrated experience working under FDA QSR, ISO 13485, or equivalent quality systems
• Working knowledge of design controls, risk management (ISO 14971), safety and performance standards (IEC 60601) and regulatory pathways for medical devices
• Experience managing component suppliers and external manufacturers
• Hands‑on prototyping capabilities spanning firmware, software and user interface design for medical devices
• Background in digital signal processing or related analytical techniques
• Demonstrated proficiency with electrical test equipment such as oscilloscopes, function generators, power supplies, and multimeters
• Self‑directed problem solver with ability to balance independent technical work and collaborative cross‑functional initiatives
• Clear technical communicator with strong documentation practices
• Prior role in an early‑stage medical device company or startup environment

• Proficiency in C, C++, C#, or Python for embedded software development and integration
• Experience with Verilog, System Verilog or VHDL for FPGA development
• Experience with electronic hardware development for medical devices
• Knowledge of IEC 60601 requirements and tests for medical electrical equipment
• Experience with ultrasound systems, ultrasound imaging, or related technologies
• Familiarity with wireless powering and data communication systems

• Meaningful Impact on life‑saving cardiac technology
• Growth Opportunity with increasing responsibility as we scale
• Collaborative Culture with experienced medical device professionals
• Competitive Compensation including equity participation and PTO
• Comprehensive Benefits including health, dental, and vision coverage

This is a full‑time, on‑site position based in the Bay Area, California. Our collaborative work environment emphasizes hands‑on development, rapid iteration, and close teamwork. While we value work‑life balance, the fast‑paced nature of startup development occasionally requires flexibility in working hours to meet critical milestones.

This position will require minimal travel outside of Bay Area, California.