Principal Security Architect

Insulet · San Diego · $196,500–$294,750 (stated in the posting)

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Job Summary

The Principal Security Architect defines the cybersecurity vision and strategy for an FDA-regulated insulin delivery system. The system has the shape of a connected IoT platform: an insulin pump, a continuous glucose monitor (CGM), iOS and Android mobile apps that serve as the patient-facing controllers and command the pump over Bluetooth Low Energy (BLE), and cloud services that receive pump and CGM data. This role sets the trust model that ties those parts together, with particular depth in public key infrastructure (PKI), identity, and cryptography.

This is a hands-on individual-contributor architecture role in R&D Security. You will set the long-term security direction, establish the standards product engineers build to, mentor senior engineers, and stay close enough to designs and critical implementations to make the hard decisions yourself. You will partner with Product Security, which sets the corporate guidance and constraints, and apply that guidance to the software and hardware of this system. You will serve on the Security Council as the R&D security architect when a design, an early program, or a field issue needs a recorded security position. You will also partner with iOS, Android, firmware, cloud, quality, and regulatory colleagues so security controls support a safe, reliable, and maintainable medical device on both mobile apps.

This is a hybrid role, with 1–2 days per week in the office.


Responsibilities:

• Define and evolve the security architecture across the pump, the iOS and Android mobile apps, CGM integrations, and the cloud, including identity, key management, session security, secure update, telemetry, and API boundaries.
• Design and govern PKI: certificate hierarchies, device and service identity, provisioning, rotation, revocation, and secure key storage on the pump, in the iOS and Android mobile apps, and in the cloud.
• Set the cryptographic approach for therapy commands and health data, including authenticated sessions, protection in transit and at rest, signing, and how keys are generated, stored, and retired.
• Own identity architecture for patients, mobile apps, pumps, and cloud services, including authentication, authorization, and least-privilege access to therapy and device data.
• Lead BLE security design for both mobile apps: pairing and bonding, session encryption, device authentication, and how each mobile app and the pump keep a trustworthy link across reconnects. The security model stays consistent across iOS and Android.
• Define security requirements for CGM and other partner integrations, including BLE sensor onboarding, authenticity of incoming data, and cloud-to-cloud trust.
• Establish security and privacy controls for protected health information, aligned with HIPAA, FDA cybersecurity expectations, and healthcare privacy obligations.
• Drive threat modeling and security risk assessment early in design, and map controls to hazards, requirements, and residual risk for a regulated quality system.
• Review architectures and critical implementations, and mentor senior engineers so security intent survives implementation.
• Partner with Product Security to apply corporate guidance and constraints to this system, including identity, cryptography, vulnerability handling, logging, and supplier expectations. When the platform cannot meet a constraint, bring the specific gap: which constraint, which limit, which alternative control, and for how long.
• Serve on the Security Council as the R&D security architect. For security by design, bring the threat model and the recommended application of Product Security’s constraints. For early-phase programs, name the constraints that will be expensive to change later and when a full design review is required. For field issues, determine what the product does and what a correct fix is, so the council can record one position on scope, severity, action, and what resolved means.
• Partner with firmware, iOS, Android, cloud, quality, human factors, and regulatory teams on interface contracts, verification evidence, and submission-ready cybersecurity documentation.
• Define how the system detects, responds to, and records vulnerabilities across the device fleet, both mobile apps, and partner-connected paths.
• Review security of shared non-UI logic where cross-platform code is used, while each therapy user interface remains native to iOS or Android.
  

Basic Qualification:

• Bachelor's degree in computer science, Electrical Engineering, or Computer Engineering.
• At least 10 years of professional experience, with substantial recent work architecting security for production connected systems.
• Demonstrated experience designing PKI and cryptographic key lifecycles, including issuance, storage, rotation, and revocation.
• Experience with identity architecture spanning devices, users, and cloud services, including authentication and authorization.
• Demonstrated Bluetooth Low Energy security experience, including pairing, bonding, and encrypted sessions between a mobile app and a constrained device.
• Experience defining security architecture across embedded software, iOS and Android mobile apps, and a cloud backend.
• Working knowledge of HIPAA and how it applies to collection, storage, and transmission of protected health information.
• Experience operating inside a regulated quality system, such as medical device, aerospace, or another design-control environment, including requirements of traceability and verification.
• Ability to write and defend architecture decisions that balance safety, security, reliability, and delivery speed.
• Clear written and verbal communication with engineers and with quality, regulatory, and clinical partners.

Preferred Qualifications:

• Experience with insulin delivery, CGM, or other Class II or Class III connected medical devices.
• Working knowledge of IEC 62304, ISO 14971, FDA design controls, and FDA premarket cybersecurity guidance.
• Applied cryptography experience: protocol selection, certificate lifecycle operations, and review of how keys are used in product code.
• Secure boot, signed firmware update, and key storage on constrained or embedded devices.
• Cloud security architecture: service identity, secrets management, least privilege, logging, and monitoring for a device fleet.
• Experience setting security requirements for third-party BLE sensors and partner cloud integrations.
• Experience contributing cybersecurity content to regulatory submissions, threat models, or design history files.
• A graduate degree in Computer Science, Electrical Engineering, or Computer Engineering, or a recognized security certification such as CISSP.
• Experience mentoring senior engineers and setting security standards across teams, as an individual contributor.

Additional Information:

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