Overview
Senior Software Quality Assurance Engineer – Strand, London, WC2R 2LS
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.
IMPORTANT: Before applying for this role, please make sure you have the right to work in the country where the role is based. Unless it clearly stipulates within in the job advert above that the hiring company is looking to or able to sponsor applicants it is deemed that the hiring employer will only consider applications from those able to comply with and work in the country where the role is based.
