Principal Advanced Algorithms Engineer (Remote/Flexible)

About the position The Principal Advanced Algorithms Engineer will play a pivotal role in translating next-generation Automated Insulin Delivery (AID) principles into Insulet's strategic insulin therapy optimization platform. This role is responsible for integrating novel algorithmic features into state-of-the-art insulin pump hardware and software, bridging the gap between research and commercial deployment. You will lead cross-functional efforts, ensure regulatory compliance, and drive innovation that directly impacts patient outcomes and product success. This is a high-impact position offering significant growth opportunities within Insulet's advanced technology organization. Responsibilities • Lead the implementation of advanced insulin therapy optimization algorithms into both commercial and experimental insulin pump systems. • Serve as the technical lead during clinical validation and commercial release phases, including in silico performance modeling and validation, clinical trial data interpretation, and iterative algorithm refinement. • Collaborate with product management to align algorithm development with business priorities and user needs. • Drive cross-functional coordination with regulatory, software, hardware, test, and marketing teams to ensure design control and regulatory compliance, with a focus on successful FDA submissions. • Conduct edge case risk analyses and develop robust mitigations for real-world use scenarios. • Present technical findings and strategic updates to leadership and non-technical stakeholders. • Mentor junior engineers and foster a culture of innovation, technical rigor, and continuous improvement. • Stay current with industry trends, regulatory guidance, and emerging technologies in AID and medical device software. • Perform other duties as required. Requirements • Master's degree (PhD preferred) in Computer Science, Electrical/Computer Engineering, Biomedical Engineering, or a related field preferred. • Minimum of 5 years of experience in algorithm development, validation, and deployment in clinical or commercial medical device settings. • Proven experience in the medical device or healthcare industry. Nice-to-haves • Proficiency in analytic and modeling tools such as Python, R, MATLAB, or equivalent. • Strong programming skills in C/C++, C#, or Java. • Experience with clinical data analysis and interpretation. • Familiarity with FDA regulatory processes, including Computational Modeling and Simulation Guidelines. • Demonstrated expertise in control systems, model-based design, and embedded systems. • Knowledge of software engineering best practices, including version control, testing, and documentation. • Experience with risk management standards (e.g., ISO 14971) and design control processes (e.g., IEC 62304). • Strong communication skills and ability to work independently while maintaining alignment with cross-functional teams. • Track record of publications, patents, or contributions to commercial AID systems is a strong plus. Benefits • 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). Apply tot his job