Lead Systems Engineer

Position Overview

We are seeking a talented and motivated Senior/ Principal 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 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.

Roles and Responsibilities

• Drive the 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

Required Qualifications

• 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

Preferred Qualifications

• 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

What We Offer

• 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

Location & Work Environment

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.