Tech Stack
AWSAzureGoogle Cloud PlatformPostgresTerraform
About the role
- Provide the technical direction and expertise needed to design, architect, integrate, operate, and govern internal and third-party digital health technologies.
- Design, architect, integrate, operate, and govern applications that process sensitive health data, share health insights, enable third-party research studies, and build participant engagement.
- Define regulatory strategy, contribute to medical risk management, and work closely with regulatory specialists to understand applicable standards and ensure standards compliance.
- Drive initiatives and programme-level outcomes required to meet targets for clinical trial recruitment, returning health insights to participants, and developing necessary regulated software where applicable.
- Lead technical oversight across product development, clinical software delivery, and architecture.
- Work with peers across the organisation and cross-functional teams to deliver outcomes.
- Mentor and lead multiple cross-functional teams, facilitate complex technical discussions, and provide direction to stakeholders at all levels including executives.
Requirements
- Experience leading the technical design, development, and delivery of precision medicine / personalised health software products or devices.
- Knowledge and experience of large scale processing and management of sensitive health data, focused on healthcare delivery and clinical trials.
- Prior experience with Azure (ideally), AWS or GCP.
- Comfortable working with Infrastructure as Code, ideally with knowledge of Terraform.
- Knowledge of good data modelling and design patterns; in-depth knowledge of relational databases (e.g. PostgreSQL) and familiarity other types of data store (blob, document, graph).
- Experience in a technical leadership role in a modern, agile development team, leading the adoption of practices like code review, TDD, CI/CD and pairing using tools like Git and GitHub.
- Experience of operationally managing software components once live, including; observability, logging, metrics, error reporting, debugging and live incident management.
- Experience working in/with cross-functional teams consisting of engineers, product, UX and non-technical stakeholders.
- Experience leading the work of multiple cross-functional teams to deliver an overall objective.
- Comfortable in facilitating complex technical discussions with organisation-wide impact, encouraging collaboration and providing direction.
- Proven ability to communicate with stakeholders and audiences at different levels, including exec level (CTO, CPO, etc).
- Proven experience developing Software as a Medical Device (SaMD) in compliance with the UK MDR 2002 and applicable international standards (ISO 14971, ISO 13485, IEC 62304, IEC 62366…):
- Demonstrated ability to produce and maintain required software lifecycle documentation required under IEC 62304 including software development plans, architecture and design specifications, unit/integration/system test protocols and reports, software requirements traceability matrices, anomaly/change records etc.
- Hands-on knowledge of quality management systems (ISO 13485), including participation in internal audits, CAPA processes, and ensuring software lifecycle documentation is inspection-ready for regulatory review.
- Strong understanding of risk management per ISO 14971, and usability engineering principles per IEC 62366.
- Familiarity with clinical safety and health software standards relevant in the UK (e.g. DCB0129/0160) and the associated regulatory expectations for safe deployment of clinical software.
- Experience of of supporting regulatory submissions (Technical Files, Design Dossiers, or equivalent), including responding to regulator/Approved Body queries on software documentation.
- Experience working in small, growing organisations with a high degree of ambiguity, where flexibility is valued.
- Expert understanding of software quality and experience leading quality improvement initiatives across multiple cross-functional teams.
- A track record of successfully mentoring both highly experienced and early career engineers.