Principal Engineer - Digital Health Products

We are hiring a Principal Engineer to join a new team working on initiatives and projects which will use the Our Future Health resource to provide personalised, actionable health insights (such as basic calculated disease risk scores and more advanced Polygenic and Integrated Risk scores) to participants and enable a large increase in the UK's ability to run clinical trials as part of the government's 10-year NHS plan. This role will be pivotal in delivering key technologies that impact participant health on a national scale.

Sitting at the intersection of technology oversight, architecture, product development, and clinical software delivery, you will provide the technical direction and expertise needed to design, architect, integrate, operate, and govern internal and third-party digital health technologies. These applications will process sensitive health data, share health insights, enable further third-party research studies, and build participant engagement.

You will also play a key role in defining regulatory strategy, contribute to medical risk management, and work with regulatory specialists to understand applicable standards, ensuring compliance by establishing procedures with a focus on Information Security, Health Information, and Medical Device standards. To fulfil this role, you will need extensive knowledge and experience of digital health applications, clinical trials, genomics, and associated regulatory requirements.

Responsibilities:

• Lead the technical design, development, and delivery of precision medicine / personalised health software products or devices.
• Manage large-scale processing and management of sensitive health data, focused on healthcare delivery and clinical trials.
• Collaborate on cloud platform strategy with Azure, AWS or GCP.
• Work with Infrastructure as Code, ideally Terraform.
• Apply good data modelling and design patterns; deep knowledge of relational databases (e.g. PostgreSQL) and familiarity with other data stores (blob, document, graph).
• Provide technical leadership in an agile development team, promoting practices like code review, TDD, CI/CD and pairing using Git and GitHub.
• Oversee operational aspects post-live, including observability, logging, metrics, error reporting, debugging and live incident management.
• Collaborate with cross-functional teams of engineers, product, UX and non-technical stakeholders.
• Lead work across multiple cross-functional teams to deliver overall objectives.
• Facilitate complex technical discussions with organisation-wide impact, encouraging collaboration and direction.
• Communicate with stakeholders at various levels, including exec level (CTO, CPO, etc).
• Develop Software as a Medical Device (SaMD) in compliance with UK MDR 2002 and applicable international standards (ISO 14971, ISO 13485, IEC 62304, IEC 62366).
• Produce and maintain required software lifecycle documentation under IEC 62304 (e.g., software development plans, architecture and design specs, test protocols and reports, traceability matrices).
• Maintain quality management systems (ISO 13485), participate in internal audits, CAPA processes, and ensure software lifecycle documentation is inspection-ready for regulatory review.
• Apply risk management per ISO 14971 and usability engineering per IEC 62366.
• Understand clinical safety and health software standards relevant in the UK (e.g. DCB0129/0160) and regulatory expectations for safe deployment of clinical software.
• Support regulatory submissions (Technical Files, Design Dossiers, or equivalent) and respond to regulator/Approved Body queries on software documentation.
• Experience working in small, growing organisations with ambiguity, where flexibility is valued.
• Demonstrate software quality excellence and lead quality improvement initiatives across cross-functional teams.
• Mentor engineers across experience levels.

Qualifications:

• Extensive experience in digital health, clinical trials, genomics, and regulatory requirements.
• Proven track record in technical leadership and delivering regulated software products.

Benefits:

• Generous Pension Scheme - employer contributions up to 12%.
• 30 Days Holiday + Bank Holidays.
• Enhanced Parental Leave.
• Cycle to Work Scheme.