2 months ago
Pleasanton, CA, USAMid Level / Senior
H1B sponsor
Base Salary
$145k - $158k/yr
Responsibilities
- Design, document, execute, and report software design verification plans, protocols, tests, and summary activities.
- Analyze requirements and software risks, define software requirements, and identify improvement opportunities in the risk-management process.
- Translate high-level requirements into documented, high-performance C++ implementations for real-time urology medical-device applications.
- Design and implement automated testing and continuous integration processes.
- Participate in code reviews, design reviews, system validation, cybersecurity assessments, and regulatory submission and audit support.
- Ensure software and development documentation comply with applicable medical-device regulatory standards and FDA guidance.
- Collaborate with computer vision, electrical engineering, and program-management teams on validation and project schedules.
- Mentor engineers, provide architectural guidance, evaluate technologies, and lead software best-practice implementation.
Requirements
- Bachelor’s degree in Computer Science, Engineering, Math, or another STEM discipline with 3-5 years of experience, or at least 6 years of professional experience developing software released to and used by customers.
- Advanced C++ development experience, including 3-5 years of C++ software development.
- Deep understanding of object-oriented analysis and design, data structures, algorithms, and software architecture.
- Strong unit, module, and integration testing experience, including expert knowledge of black-box and white-box testing methods.
- Extensive hands-on experience with software design verification in medical-device development and experience with risk management and FMEA.
- Experience developing automated software quality-assurance tests and strong Python experience.
- Experience working in Linux command-line environments.
- Preferred experience with STL, Boost, Qt, Make, CMake, cross-compilation, Linux boot and startup processes, Git, CI/CD, CUDA, GPU programming, NVIDIA Jetson, computer vision, machine learning, model-based testing, and regulated medical-device software.
- Knowledge of IEC-62304, ISO-13485, and ISO-14971 is preferred.
- Must be able to meet physical, hazardous-material, protective-equipment, vehicle-operation, and vaccination-compliance requirements.
Benefits
- Competitive base salary of $145,000-$158,000 plus a variable incentive plan.
- Stock options, 401(k), healthcare insurance, and paid vacation.
- Pleasanton, California-based role in a diverse, collaborative work environment.
- Applicants must be legally authorized to work in the United States and comply with applicable vaccination requirements.
About Calyxo
Calyxo develops medical devices for urologists to improve the treatment and removal of kidney stones, sold to hospitals and ambulatory surgery centers. Its product portfolio targets ureteroscopic stone procedures and related workflows, with revenue from device sales and clinical adoption in urology practices. Founded in 2016 and headquartered in Pleasanton, California, the company is privately held and operates in the medical equipment manufacturing sector.