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: Architect with 'future-proofing' in mind. Anticipate the needs of future commercialization (e.g., US hospital EMR integration, fleet management, recurring revenue feature toggles, international deployment, federated learning…etc) and build flexible interfaces that will allow a future Product Manager to drive roadmap velocity 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
- 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
- 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
- Technical Mentorship: Mentor a growing team of senior and staff engineers, fostering a culture of technical excellence, rigorous review, and psychological safety
- Bridge to Product, Clinical, & Regulatory: Translate product and clinical performance goals into concrete, actionable engineering specifications and development timeline. Ensure that our software capabilities align with 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 systems
- Deep Medical Device Experience: Proven experience delivering regulated software (IEC 62304 Class B/C) through the full lifecycle, from concept to 510(k)/ De Novo/ PMA submission and post-market support. You understand the 'why' behind the regulations
- Product-Aware Mindset: Demonstrated ability to make architectural trade-offs that favor long-term product flexibility and user experience. You can give examples of how you designed a system to accommodate future business needs that weren't yet fully defined
- Full-Stack Technical Mastery: Proficiency in modern systems languages (Rust, C++, or Go) and Python. Deep expertise in cloud infrastructure (AWS/GCP), Infrastructure as Code (Terraform), and containerization (Docker/Kubernetes)
- Security & Data Privacy: Experience designing HIPAA/GDPR-compliant systems, including encryption, audit logging, and secure data transmission
- SaMD Commercialization: Experience with 'Software as a Medical Device' (SaMD) products that have successfully scaled in the market
- EHR/EMR Integration: Hands-on experience integrating software with hospital IT systems (Epic, Cerner) using standards like HL7 or FHIR
- Cybersecurity Expertise: Background in PKI, device authentication, or threat modeling for connected devices
- Cardiology Domain Knowledge: Familiarity with cardiac diagnostics, ECG workflows, or similar physiological monitoring platforms