Insulet Corporation-posted 3 months ago
$142,950 - $214,425/Yr
Full-time • Senior
Remote • Acton, MA
Miscellaneous Manufacturing

The Sr Staff 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.

  • Primary driver of the implementation of advanced insulin therapy optimization algorithms into both commercial and experimental insulin pump systems.
  • Collaborate with other team members 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.
  • Execute 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.
  • Minimum of 3 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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