Insulet Corporation-posted 4 months ago
$166,275 - $249,412/Yr
Full-time • Senior
Remote • Acton, MA
Miscellaneous Manufacturing

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.

  • 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.
  • 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.
  • 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.
  • 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).
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