Medical Device Embedded Systems Manager

Ventaris Surgical; San Carlos (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Ventaris Surgical in San Carlos, CA is seeking an Electrical Engineering & Firmware Manager to lead development, testing, and regulatory compliance for our next-generation ureteroscopic system. You will oversee contract developers and manufacturers, ensure hardware-firmware integration, and drive V&V for FDA/IEC standards.

The ideal candidate has medical device experience, embedded systems expertise, and strong leadership.

Qualifications

• 8+ years of experience in medical device development and embedded systems.
• Proven track record managing contract developers, manufacturers, and external testing labs.
• Expertise in embedded software (C/C++, RTOS) and medical hardware design.
• Experience with cybersecurity best practices.
• Strong leadership, communication, and cross-functional collaboration.
• Regulatory testing and design controls knowledge (FDA/IEC 60601/IEC 62304).

Responsibilities

• Lead hardware/firmware development and integration for medical devices.
• Oversee contract engineers and manufacturers; manage design transfer and production scaling.
• Drive V&V planning, testing, and regulatory submissions.
• Ensure compliance with FDA, IEC 60601, IEC 62304, and HIPAA.
• Develop risk management and safety-critical design considerations.
• Collaborate with RA/QA, clinical, and operations teams.

Skills

Embedded systems

C/C++

RTOS

Medical device development

Regulatory compliance

Project management

Vendor management

Cybersecurity

Education

Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, or related field

Tools

ECAD tools

PCB design

Job description

Ventaris Surgical in San Carlos, CA is seeking an Electrical Engineering & Firmware Manager to lead development, testing, and regulatory compliance for our next-generation ureteroscopic system. You will oversee contract developers and manufacturers, ensure hardware-firmware integration, and drive V&V for FDA/IEC standards.

The ideal candidate has medical device experience, embedded systems expertise, and strong leadership.