Senior Software Quality Assurance Engineer - Strand, London, WC2R 2LS

ZipRecruiter; London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A healthcare technology company in London seeks a Senior Software Quality Assurance Engineer to lead the implementation of medical device software quality assurance processes. The successful candidate will work within a dynamic team, focusing on meeting ISO 13485 and IEC 62304 standards while transitioning innovative software for neurosurgical planning into clinical use. This full-time role offers a fixed-term contract until July 2028.

Qualifications

• Experience in software as a medical device required.
• Expertise in ISO 13485 and IEC 62304 needed.
• Background in regulatory affairs for MedTech startups desired.

Responsibilities

• Lead implementation of software quality assurance processes.
• Create necessary documentation and apply quality system procedures.
• Collaborate with a team of software engineers.

Skills

Software as a medical device

Quality management implementation

ISO 13485

IEC 62304

Regulatory affairs supporting MedTech start-up organisations

Job description

Job Description

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 13485
• 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 engineers designing and translating technology into the clinical setting. The project will follow the King’s College London ISO 13485 Quality Management System (QMS), supported by the QMS team at the London Institute for Healthcare Engineering (LIHE), ensuring internal and regulatory requirements are met.

About The Role

We are looking for someone passionate about helping 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 ISO 13485, IEC 62304, and IEC 82304 requirements for the Epilepsy Navigation (EpiNav) Software Platform.

EpiNav provides state-of-the-art computer-assisted support for planning stereotactic neurosurgery procedures. It has been in daily clinical use at the Hospital for Neurology and Neurosurgery for over 7 years, aiding neurologists and neurosurgeons in treating patients with medically refractory epilepsy and brain tumours. The software enables clinicians to use complex multi-modal imaging to inform surgical decisions. Based on the early success of EpiNav in improving patient care, we are now seeking to refine the software, transitioning it from research-only to a regulated medical device.

The successful candidate will work with a team of three software engineers to develop processes, apply quality system procedures, and create necessary documentation. EpiNav already employs industry standards, including maintained code repositories, unit tests, and continuous integration. The candidate will undertake training to understand the existing QMS infrastructure within the School and team, help maintain these processes, and recommend improvements where appropriate.

This is a full-time position (35 hours per week) with a fixed-term contract until 31/07/2028.