The posting
About Albus Health
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.
The opportunity
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 management system.
- Strong practical knowledge of ISO 14971 and risk-based verification, including verification of risk-control measures.
- Experience reviewing and improving requirements, test protocols, objective evidence, traceability matrices and verification reports.
- Experience with embedded software/firmware verification and hardware/software interactions.
- Experience with connected devices and web/cloud software, including interfaces between device, backend/cloud and web applications.
- Excellent technical writing and documentation skills.
- The confidence to challenge constructively, make risk-based judgements and explain clearly why evidence is or is not adequate.
- A hands-on approach suited to a small, fast-moving company: you must be willing to move from senior review into detailed remediation and mentoring.
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.
Useful additional experience
- Multiple FDA submissions or experience responding to FDA questions relating to software or verification documentation.
- Integrating electrical safety, EMC/radio, manufacturing or other specialist hardware evidence into a device verification package.
- Familiarity with medical-device cybersecurity verification and FDA cybersecurity expectations. A specialist supplier will lead this area.
- Experience in small or scaling medical-device companies where responsibilities cross traditional functional boundaries.
- Mentoring software or test engineers who are new to medical-device verification.
Benefits
Working arrangements
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.
