Senior Software Quality Assurance (QA) Engineer

About us:

We are seeking experts in medical software quality management and assurance to join our team and help translate a novel neurosurgical planning software into clinical practice.

We welcome applications from individuals with experience in:

• Software as a medical device
• Quality management implementation
• ISO 13458
• IEC 62304
• Regulatory affairs supporting MedTech start-up organisations

This post will be embedded in the School of Biomedical Engineering & Imaging Sciences, a vibrant community of engineering designing and translating technology into the clinical. The project will follow the King’s College London ISO13485 Quality Management System (QMS) and this role will be supported by the QMS team at the London Institute for Healthcare Engineering (LIHE) who will collaborate closely with the group to ensure internal and regulatory requirements are met.

About the role:

We are looking for someone with a passion for helping to translate medical technology into clinical settings as part of a small dynamic team of software engineers. The successful applicant will help lead the implementation of medical device software quality assurance processes to meet the requirements of ISO 13485, IEC 62304 and IEC 82304 for the Epilepsy Navigation (EpiNav™) Software Platform.

EpiNav™ provides state-of-the-art computer-assisted support for the planning of stereotactic neurosurgery procedures. It has been in daily clinical use at the National Hospital for Neurology and Neurosurgery for over 7 years aiding neurologist and neurosurgeons in the surgical treatment of patients with medically refractory epilepsy and brain tumour biopsy. This software enables clinicians to use complex multi-modal imaging to inform surgical decisions. Based on the early success of EpiNav™ to help improve patient care we are now seeking to refine the software, bringing it from only suitable for research into a regulated medical device.

In this role the successful candidate will be working with a team of three software engineers to lead the development of processes, apply quality system procedures, and create appropriate documentation. EpiNav™ as a software platform is already using industry standards including a maintained code repository, unit tests, and continuous integration. The successful candidate will undertake training to understand the existing QMS infrastructure in place within the School and team. As part of this role, it is expected that the successful candidate will help to maintain these processes and provide recommendations for improving processes where appropriate.

This is a full-time  post (35 Hours per week), and you will be offered a fixed-term contract until 31/7/2028

About you:
(the candidate)

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

1. Degree or equivalent in engineering discipline (biomedical, computer science, software, electronic, quality management).
2. Experience of working to quality system procedures
3. Experience of preparing and writing standard operating procedures
4. Knowledge applying quality system standards, software development standards and regulations, e.g. ISO 13485, IEC 62304, MDD, and MDR
5. Experience of working with code repositories and continuous integration servers.

• Experience of designing software tests including unit tests, integration tests, and system tests
• Excellent organisation, written and verbal communication and skills

Desirable criteria

1. Familiarity with the regulatory environment around Deep Learning or Machine Learning algorithms
2. Experience applying quality system standards, software development standards and regulation, e.g. ISO 13485, IEC 62304, MDD, and MDR
3. Experience working within a team of software engineers to apply quality system stands and regulations

This post is subject to Disclosure and Barring Service and/or Occupational Health clearances.

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