Principal Medical Device Verification Engineer

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.

What you will do

• Review system, hardware and software requirements for clarity, completeness, testability and suitability for verification.
• Review verification plans, protocols/test cases, acceptance criteria, execution records, objective evidence, anomalies and formal reports.
• Assess end‑to‑end traceability between requirements, hazards and risk controls, verification activities, results and reports.
• Assess verification coverage across hardware, embedded software, MyAlbus and relevant backend/cloud and device‑to‑cloud functionality.
• Apply IEC 62304, ISO 13485, ISO 14971 and relevant FDA expectations pragmatically to the technical evidence.
• Identify gaps that could create regulatory or technical risk in the 510(k) submission and define proportionate remediation.
• Roll up your sleeves to improve or rewrite requirements, test protocols, reports, traceability records and other technical documentation where needed.
• Review how specialist evidence produced by others fits into the overall evidence pack, including hardware safety, radio, manufacturing and cybersecurity deliverables.
• Ensure deviations, anomalies and unresolved issues are appropriately assessed, documented and dispositioned.
• Coach software engineers and testing colleagues on what good verification evidence looks like for an FDA‑regulated medical device.
• Provide a strong technical view on verification readiness while working closely with our Head of QARA, who retains overall quality and regulatory authority.

Requirements

What we are looking for

• Substantial hands‑on verification experience with regulated medical devices, ideally at Senior, Lead or Principal level.
• Strong practical experience applying IEC 62304 to software‑containing medical devices.
• Strong experience working within an ISO 13485 quality…