Head of Software Engineering

Software as a Medical Device

Location: Remote (UK-based), London HQ

Contract: Full-time, permanent

Reports to: CTO

Compensation: £100k - £120k + equity

Stage: Funded, venture-backed

About Our Client

Our client is a spinout from a leading UK university, building AI software that analyses standard 12-lead ECGs to predict disease before symptoms appear. They have validated models across 4 continents and 6M+ ECGs and are pursuing FDA 510(k) and EU MDR clearance. The founding team combines deep cardiology and electrophysiology expertise with AI research and commercial experience.

The Role

They are hiring their first senior engineering hire to build the production software platform that brings AI models into clinical workflows. This is a foundational role: you will own the software architecture, cloud infrastructure, and critically the regulatory software lifecycle.

They need someone who has been through the process of bringing a medical device to FDA clearance or EU MDR approval and understands what "production-grade" means in a regulated environment. This is not a long term solo individual contributor role, within 12–18 months, you will grow into leading a team of 4–6 engineers across backend, data architecture, DevOps, and product engineering.

What You'll Do

Engineering & Architecture

• Design and build scalable, secure backend services and APIs for clinical AI inference and data processing
• Own cloud infrastructure (AWS), deployment pipelines, monitoring, and security controls
• Collaborate with the AI research team to deploy and serve machine learning models in production
• Establish engineering best practices across code review, testing, CI/CD, and documentation

Data Architecture & Integration

• Design and maintain the data ingestion layer
• Integrate with Electronic Health Record systems and clinical data standards (FHIR, HL7)
• Build scalable pipelines that enable rapid onboarding of new hospital clients and ECG device types without re-engineering the core platform

Regulatory & Compliance

• Lead the software development lifecycle under IEC 62304 – architecture documentation, risk management, verification, and validation
• Contribute to FDA 510(k) and EU MDR submission with software-related technical documentation
• Work within an ISO 13485 QMS framework and contribute to design FMEA, traceability, and risk management processes

Leadership & Team Building

• Contribute to the product roadmap and technical strategy alongside the CTO
• Help define the engineering team structure and hiring plan as the company scales
• Mentor and manage future engineering hires, establishing a high-performance engineering culture from day one
• Work closely with a contracted development partner (ISO 13485-accredited) during the current build phase, with a view to progressively bringing development capability in-house

What We're Looking For

Technical & Regulatory

• 5+ years of professional software engineering experience with significant backend and infrastructure work
• Direct experience contributing to a medical device that achieved FDA clearance or EU MDR/CE marking – this is essential
• Working knowledge of IEC 62304 and ISO 14971 in practice, not just theory
• Familiarity with ISO 13485 is strongly preferred
• Strong proficiency in Python; experience with production frameworks (Flask, FastAPI)
• Experience with cloud platforms (AWS preferred), Docker, and CI/CD pipelines
• BSc/MSc in Computer Science, Software Engineering, or equivalent experience

Leadership & Growth

• Demonstrated experience leading, mentoring, or managing other engineers
• Track record of working autonomously with high ownership in a small team or early-stage environment
• Ability to translate between technical implementation and business or clinical requirements
• Comfortable making architectural decisions that balance speed, quality, and regulatory compliance

Also Valuable

• Experience with healthcare data interoperability (FHIR, HL7, DICOM)
• Exposure to ML model serving, MLOps pipelines, or ML frameworks (TensorFlow, PyTorch)
• Understanding of GDPR, HIPAA, or UK Data Protection Act compliance
• Experience with Infrastructure as Code (Terraform, CloudFormation, AWS CDK)
• Experience designing data ingestion or ETL pipelines across heterogeneous source systems

What's On Offer

• Competitive salary and equity in an early-stage company with significant upside
• The opportunity to be the first senior engineering hire and define the technical foundation
• Direct collaboration with world-class clinician-scientists
• Work on AI with measurable impact on cardiovascular patient outcomes
• A clear growth path into leading the engineering organisation through regulatory clearance and commercial deployment