Medical Device Software Testing Jobs in California

[Position]
Senior Software Engineer
[About Our Client]
Research & Development hub for artificial intelligence and deep learning technologies and is also home to a dedicated medical device software team focused on the development of advanced, safety-critical healthcare solutions.
[Job Summary]
We are seeking a Senior Software Engineer to play a key role in maintaining, evolving, and selectively developing our Ez-X medical X-ray imaging system.
This role primarily focuses on maintaining and stabilizing the existing C++ software platform, supporting the C# GUI architecture, and implementing business logic at the platform level. In addition, the role includes re-implementing and adapting existing business logic using a newly developed internal software platform, ensuring functional equivalence, system stability, and seamless integration.
While new feature development is part of the role, a significant portion of the work involves long-term platform maintenance, system optimization, and system-level integration across imaging algorithms, control systems, and X-ray hardware.
As medical device development is iterative and subject to regulatory, technical, and business considerations, specific responsibilities, priorities, and technical focus areas may evolve over time, provided they remain aligned with the scope and seniority of this role.
You will act as a technical leader within the software team and collaborate closely with Vision, Control, Mechanica, Platform, and X-Ray hardware teams.
[Job Description]
The responsibilities listed below describe the primary functions of this role but are not intended to be an exhaustive list. Additional responsibilities may be assigned as needed, provided they are consistent with the employee's role, expertise, and professional experience.
- Design, implement, and maintain C++ software platform components and shared interface libraries
- Architect and develop C# GUI frameworks supporting end-to-end medical imaging and clinical workflows
- Act as a technical lead for a team, aligning system requirements, architecture, and development priorities in close collaboration with the software group leader
- Serve as the technical bridge across software, hardware, and research teams, leading design reviews and driving key architectural and technical decisions
- Support software verification, validation, and documentation activities for regulatory submissions, collaborating closely with QA and regulatory teams during FDA submissions and audits
- Mentor junior engineers, conduct code reviews, and promote best practices in software development
Requirements
Required Qualifications
- Bachelor's in Computer Science, Software Engineering, or equivalent
- 5+ years of professional software development experience
- Strong proficiency in modern C++
- Experience with C# GUI development
- Solid understanding of multi-threading, synchronization, and performance optimization
- Able to work in US without any Work Visa sponsor/transfer/Extension/ support, now and future
Preferred Qualifications
- Master's degree in Computer Science, Software Engineering, or equivalent
- Experience designing software architectures for complex systems
- Prior experience in medical device software development
- Knowledge of FDA regulations, IEC 62304, ISO 14971
- Experience with medical imaging, DRR, CT, or X-ray systems
- Experience with real-time or near-real-time systems
- Familiarity with software safety classification and risk management
- Experience supporting FDA submissions or audits
- Bilingual in English and Korea would be a plus
Benefits
[What's On Offer]
- Key technical role in next-generation medical X-ray systems
- Direct impact on FDA-regulated medical products
- Leadership opportunities in a growing US medical device team
- Competitive salary and benefits (US market)
- Long-term stability and global product exposure