Senior Software Development Engineer

Location: San Diego, CA

A venture-backed medical device company developing an advanced energy-based cardiac therapy platform is seeking a hands-on Senior Software Development Engineer. This role focuses on application development for a Class III medical device system and involves close collaboration with hardware, systems, quality, and clinical teams in a fast-paced environment.

Key Responsibilities

Software Development

• Design, develop, and maintain application-level software using C++, Qt, and Linux.
• Build automation, testing, and integration tools using Python.
• Participate in architecture discussions, peer reviews, and documentation to meet strict regulatory standards.
• Own software deliverables through design, implementation, verification, and validation.
• Collaborate cross-functionally with hardware, systems, clinical, and regulatory teams.

Quality & Testing

• Develop and execute test cases aligned with regulatory and validation requirements.
• Maintain documentation and traceability using Helix or similar test management tools.
• Troubleshoot, document, and resolve software defects with strong attention to compliance.
• Support design verification and validation throughout the development lifecycle.

Cross-Functional & Field Support

• Provide technical support for clinical and preclinical (including animal) studies.
• Gather user feedback and translate insights into product improvements.
• Contribute to regulatory documentation (FDA, ISO 13485) and quality processes.
• Adapt effectively in a dynamic startup environment where needs shift between development, testing, and field support.

Required Qualifications

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related field.
• 5+ years of professional software development experience.
• Experience developing Class III medical devices in regulated environments.
• Strong understanding of FDA regulations and ISO 13485.
• Advanced proficiency in C++ and Qt.
• Strong experience with Linux operating systems.
• Proficiency with Python for automation and testing.
• Experience with test management systems (Helix preferred).
• Willingness to support preclinical studies as needed.
• Proven success working in collaborative, cross-functional engineering environments.
• Ability to excel in fast-paced, resource-constrained settings.

Preferred Qualifications

• Experience with FPGA development or hardware–software integration.
• Background in startup or early-stage medical device environments.
• Contributions to regulatory submissions (510(k), PMA, IDE).
• Knowledge of real-time systems or embedded software fundamentals.
• Familiarity with design controls and quality management systems.