Principal Software Engineer, Medical Devices

SandboxAQ is a high-growth company delivering AI solutions that address some of the world's greatest challenges. They are seeking a Principal Software Engineer to serve as the Technical Lead for their medical device software platform, focusing on software architecture and ensuring compliance with medical device standards.

Responsibilities:

• Own the Platform Architecture: Serve as the final technical authority for the end-to-end software stack, spanning embedded firmware, in-field Linux devices, cloud data pipelines (AWS/GCP), and the clinician-facing web application
• Product-Ready Foundation: Design clear and flexible interfaces such that our platform can evolve with our product roadmap without major refactors
• Data Path Integrity: Design and maintain a HIPAA-compliant, production-grade data platform that ensures data confidentiality, integrity, and availability from the sensor to the cloud
• Hands-on Engineering: This is a player-coach role. You will write code, review complex PRs, debug hardware-software integration issues in the lab, and configure CI/CD pipelines. You lead by doing, setting the standard for code quality and testing. You know what “good” looks like
• Technical Mentorship: Mentor a growing team of senior and staff engineers, fostering a culture of technical excellence, rigorous review, and psychological safety
• Drive Quality & Compliance: Lead the engineering team’s adherence to applicable medical device standards (e.g. IEC 62304, ISO 14971) and regulations. You are the gatekeeper ensuring that design outputs (code) meet design inputs (requirements) and that our "move fast" culture never compromises patient safety and critical product functions. Scale strong engineering practices across the team, including design reviews, code review quality, test strategy and technical documentation
• Cross-functional execution: Partner with Product, Clinical and Regulatory stakeholders to translate product requirements, clinical performance goals and regulatory inputs into concrete, actionable technical plans, engineering specifications and development timelines. Ensure that our software architecture, implementation and documentation support our clinical study needs and regulatory plans (e.g. 510(k) and De Novo)

Requirements:

• 10+ years of software engineering experience, with at least 4 years serving as a Technical Lead or Architect for complex, distributed, and cloud-heavy systems
• Proven experience delivering regulated software (IEC 62304 Class B/C) through the full product lifecycle
• Proficiency in modern systems languages (Rust, C++, or Go) and Python
• Deep expertise in cloud infrastructure (AWS/GCP), Infrastructure as Code (Terraform), containerization (Docker/Kubernetes) and observability (Cloudwatch/Datadog)
• Experience designing HIPAA/GDPR-compliant systems, including encryption, audit logging, and secure data transmission
• Demonstrated ability to make architectural trade-offs that favor long-term product flexibility and user experience
• Experience with 'Software as a Medical Device' (SaMD) products that have successfully scaled in the market
• Hands-on experience integrating software with hospital IT systems (Epic, Cerner) using standards like HL7 or FHIR
• Background in PKI, device authentication, or threat modeling for connected devices
• Familiarity with cardiac diagnostics, ECG workflows, or similar physiological monitoring platforms