Salary
💰 $166,275 - $249,413 per year
About the role
- Lead technical implementation of next-generation Automated Insulin Delivery (AID) algorithms
Translate research-grade algorithm designs into robust commercial-grade software
Integrate algorithms with insulin pump hardware/software
Apply modern software development practices: automated unit testing, validation, requirement-driven test generation, AI-assisted validation and simulation
Collaborate cross-functionally (regulatory, software, hardware, clinical, marketing) for design control and regulatory compliance and FDA submissions
Conduct risk analyses and develop mitigations for real-world algorithm behavior
Mentor junior engineers and present technical findings to leadership
Stay current with industry trends and perform other duties as required
Requirements
- Ph.D. in Computer Science, Electrical/Computer Engineering, Biomedical Engineering, or related field or Master’s with exceptional experience
Minimum of 5 years experience in algorithm development, validation, deployment in clinical or commercial medical device settings
Proven experience in the medical device or healthcare industry
Proficiency in analytic and modeling tools such as Python, R, MATLAB
Strong programming skills in C/C++, C#, or Java
Experience with clinical data analysis and interpretation
Familiarity with FDA regulatory processes, Computational Modeling and Simulation Guidelines
Expertise in control systems, model-based design, embedded systems
Knowledge of software engineering best practices: version control, CI/CD, documentation
Experience with risk management standards (ISO 14971) and design control processes (IEC 62304)
Experience with automated testing frameworks and simulation environments
Publications, patents, or contributions to commercial AID systems a plus
Ability to work independently and cross-functionally