Design Assurance Lead; Software​/SaMD)( office locations

Job Description

We are seeking a Design Assurance Lead to drive excellence in software quality assurance at Genomics England, shaping organisational practice and supporting the delivery of an enhanced software development lifecycle aligned with future UK Medical Device Regulations.

• Lead and evolve software quality assurance processes across Genomics England to ensure safe, reliable, and impactful digital and genomic services.
• Shape and maintain quality frameworks that enable secure, ethical, and compliant software delivery in a data‑driven healthcare environment.
• Support the development and maturity of the Software Development Lifecycle (SDLC), aligned with UK Medical Device Regulations and organisational priorities.
• Ensure quality, safety, and regulatory requirements are embedded from early design through to delivery and ongoing operation.
• Drive compliance with key standards, including IEC 62304, across Software as a Medical Device (SaMD) and digital health solutions.
• Provide expert guidance on risk management activities, ensuring patient safety, data integrity, and regulatory compliance are consistently maintained.
• Partner closely with engineering, software QA, and QIRA teams to embed clear and practical quality requirements across delivery.
• Strengthen requirements management, traceability, and verification & validation (V&V) practices across the software lifecycle.
• Review and improve quality documentation, procedures, and configuration management to ensure transparency, auditability, and compliance.
• Champion a culture of quality by design, supporting teams to deliver innovative solutions while maintaining high standards of safety, trust, and regulatory assurance.

• Experience in software development or software quality assurance within a regulated environment, ideally in healthcare, digital health, or Software as a Medical Device (SaMD), with understanding of UK MDR / EU MDR expectations.
• Solid knowledge of regulated software development standards and frameworks, including IEC 62304, with awareness of ISO 13485 and ISO 14971.
• Experience contributing to the design, improvement, or governance of the Software Development Lifecycle (SDLC), including embedding quality and compliance within Agile or Dev Ops environments.
• Experience supporting risk management activities and working within or alongside a Quality Management System (QMS), including risk assessment, documentation control, audit readiness, and regulatory inspection support.
• Effective collaborator, working with engineers, software QA, and quality and regulatory teams to align technical delivery with patient safety and compliance.
• Confident communicator and stakeholder engager, with the ability to influence positively and translate regulatory expectations into practical, actionable guidance for teams.

Note: This is not a software testing role. It is a quality assurance and compliance role requiring significant understanding of software engineering and delivery practices.

MSc/BSc Degree in Engineering, Quality, Architecture, Design or equivalent.

• Generous Leave: 30 days’ holiday plus bank holidays, additional leave for long service, and the option to apply for up to 30 days of remote working abroad annually (approval required).
• Family‑Friendly: Blended working arrangements, flexible working, enhanced maternity, paternity and shared parental leave benefits.
• Pension & Financial: Defined contribution pension (Genomics England double‑matches up to 10%, however you can contribute more if you wish), Life Assurance (3x salary), and a Give As You Earn scheme.
• Learning & Development: Individual learning budgets, support for training and certifications, and reimbursement for one annual professional subscription (approval required).
• Recognition & Rewards: Employee recognition programme and referral scheme.
• Health & Wellbeing: Subsidised gym membership, a free Headspace account, and access to an Employee Assistance Programme, eye tests, flu jabs.

Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity, diversity and inclusion…