Albus Health is an Oxford University spin-out transforming how health data is collected and used in clinical trials and drug development.
We have developed Albus Home, a contactless multisensory platform that continuously captures physiological and behavioural data during sleep without wearables or user interaction.
Our technology combines our own purpose-built hardware and embedded software with cloud-based software and data processing. Albus Home devices collect sensor data, including audio and radar, and connect to our cloud infrastructure for remote management and data transfer. Signal-processing and machine-learning pipelines then transform this data into clinically useful measures such as cough counts, breathing rate and heart rate.
Our technology is already deployed internationally in clinical trials, primarily with pharmaceutical companies, and its use is growing rapidly.
As we expand the medical device elements of the Albus Home Platform, we are strengthening our regulatory, verification and quality capabilities, including our work towards FDA clearance in the US.
We are looking for a highly experienced medical-device verification engineer to join us for an initial three-month contract, with the possibility of extension.
The role will support our ongoing work to strengthen the verification evidence and technical documentation associated with regulated medical-device development and FDA submissions.
This is a senior, hands-on role. You will review existing requirements, verification approaches, test evidence and technical documentation, identify gaps or weaknesses, and work directly with engineering, quality and regulatory colleagues to resolve them.
We are looking for someone who can bring strong practical judgement about what constitutes clear, complete and defensible verification evidence in a regulated environment, and who is comfortable both challenging existing work and helping the team improve it.
FDA 510(k) experience
Direct experience supporting FDA 510(k) submissions for software-containing medical devices is strongly preferred, particularly where you personally prepared, reviewed or remediated verification evidence included in the submission. We may also consider an exceptional medical-device verification specialist whose direct 510(k) experience is more limited but who has strong FDA knowledge and otherwise closely matches the role.
This is an initial three-month contract with potential extension to 6+ months. We need someone who can start as soon as possible, ideally within weeks. We expect some office attendance during onboarding and periodically thereafter; once established, most of the work can be performed remotely. UK-based candidates are preferred, although candidates based further away may be considered where practical travel and effective collaboration are possible.
At Albus Health, we have developed Albus Home, a completely passive and contactless home monitoring device that monitors patients while they sleep without burdening them. We capture physiological metrics such as respiratory rate, cough and more, and environmental metrics such as air quality, humidity and temperature. Our solution enables the capture of a high quantity and quality of data from remote monitoring in research and clinical care.
