Design Assurance Lead (SoftwareSaMD)(we have office locations in Cambridge, Leeds and London)

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.

Everyday responsibilities include:

• 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.

Skills & experience for success:

• 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 DevOps 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.

Qualifications :

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

Additional Information :

Salary from: 75000

Closing date for applications - Monday 1st June 

Being an integral part of such a meaningful mission is extremely rewarding in itself but in order to support our people were continually improving our benefits package. We pride ourselves on investing in our people and supporting them to achieve their career goals as well as offering a benefits package including: 

• 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.

Equal opportunities and our commitment to a diverse and inclusive workplace 

Genomics England is actively committed to providing and supporting an inclusive environment that promotes equity diversity and inclusion best practice both within our community and in any other area where we have influence. We are proud of our diverse community where everyone can come to work and feel welcomed and treated with respect regardless of any disability ethnicity gender gender identity religion sexual orientation or social background. 

Genomics Englands policies of non-discrimination and equity and will be applied fairly to all people regardless of age disability gender identity or reassignment marital or civil partnership status being pregnant or recently becoming a parent race religion or beliefs sex or sexual orientation length of service whether full or part-time or employed under a permanent or a fixed-term contract or any other relevant factor.  

Genomics England does not tolerate any form of discrimination harassment victimisation or bullying at work. Such behaviour undermines our mission and core values and diminishes the dignity respect and integrity of all parties. Our People policies outline our commitment to inclusivity. 

We aim to remove barriers in our recruitment processes and to be flexible with our interview processes. Should you require any adjustments that may help you to fully participate in the recruitment process we encourage you to discuss this with us. 

Culture

We have four key behaviours that represent what we would like Genomics England to feel like and the culture we want to encourage in order for us to achieve our mission. These behaviours help us all work well together deliver on our outcomes celebrate our successes and share feedback with each other. You can read about these and other aspects of our culture here Culture Genomics England

Blended working model

Genomics England operates a blended working model as we know our people appreciate the flexibility that hybrid working can bring. We expect most people to come into the office a minimum of 2 times each month. However this will vary according to role and will be agreed with your team leader. There is no expectation that people will return to the office full time unless they want to however some of our roles require full time on site attendance e.g. lab teams reception team. 

Our teams and squads have and will continue to reflect on what works best for them to work together successfully and have the freedom to design working patterns to suit beyond the minimum. Our office locations are: Canary Wharf Cambridge and Leeds.

Onboarding background checks

As part of our recruitment process all successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check.  We therefore require applicants to disclose any previous offences at point of application as some unspent convictions may mean we are unable to proceed with your application due to the nature of our work in healthcare. 

Remote Work :

No

Employment Type :

Full-time