Electrical Engineering & Firmware Manager

Ventaris Surgical is an early-stage medical device company headquartered in San Carlos, CA, founded in 2024. We're developing a next-generation ureteroscopic system designed to help surgeons achieve complete kidney stone treatment — reducing the physical and cognitive burden of the procedure so surgery is simpler, easier, faster, and patients get a stronger path to recovery.

Kidney stone disease is one of the world's most common urologic conditions — nearly 1 in 10 people will experience a kidney stone in their lifetime, and more than 500,000 people undergo kidney stone surgery in the U.S. every year. The pain is often rated comparable to or worse than childbirth, and roughly half of patients live with the fear that their stone will return.

Today's surgical tools make it difficult for surgeons to consistently achieve complete stone clearance — we're changing that.

We are seeking a highly skilled Electrical Engineering & Firmware Manager to lead the development, testing, and regulatory compliance efforts for our cutting-edge medical devices. In this role, you will oversee contract developers and manufacturers, ensure seamless hardware-firmware integration, and drive product testing for regulatory clearance (e.g., FDA, IEC 60601, ISO 13485).

The ideal candidate will have experience in medical device development, embedded systems, and regulatory testing, along with strong leadership and project management skills.

• Oversee the design, development, and integration of embedded systems for medical devices, ensuring compliance with FDA and international standards.
• Create and/or review and approve electrical schematics, PCB layouts, and firmware architectures to ensure reliability and manufacturability.
• Guide contract engineers and internal teams on safety-critical design considerations, including risk management and failure mode analysis.
• Implement best practices for medical-grade embedded software (IEC 62304) and hardware safety requirements (IEC 60601).
• Manage external contract manufacturers (CMs), software developers, and hardware suppliers, ensuring quality and timeline adherence.
• Oversee the selection, negotiation, and performance of vendors to optimize design transfer and production scalability.
• Collaborate with cross-functional teams (RA/QA, clinical, operations) to ensure smooth device development and manufacturing.

• Lead hardware/firmware verification & validation (V&V) activities, including test plan development, execution, and reporting for regulatory submission.
• Coordinate with third-party test labs for EMC, electrical safety, biocompatibility, and cybersecurity testing.
• Ensure compliance with FDA, IEC 60601, IEC 62304, and HIPAA for medical software and hardware.
• Process Optimization & Risk Management
• Establish test automation and validation frameworks to improve efficiency in compliance testing.
• Drive continuous improvement initiatives to enhance device reliability, cybersecurity, and manufacturability.

• Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related field.
• 8+ years of experience in medical device development, embedded systems, or related fields.
• Proven experience managing contract developers, manufacturers, and external testing labs.
• Expertise in embedded software development (C/C++, RTOS, microcontrollers) and medical hardware design.
• Experience with cybersecurity best practices.
• Excellent project management, communication, and problem-solving skills.

• High impact from day one — we're a small team, and every role is mission-critical.
• A clear, compelling mission: every…