Albus Health
Principal Medical Device Verification Engineer
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About Albus Health
Albus Health develops the Albus Home Platform, a connected health technology platform designed for use in participants’ homes. We are preparing parts of the platform to become a medical device and are working towards an FDA 510(k) submission.
The opportunity
We are looking for a highly experienced medical-device verification engineer to join us for an initial three-month contract and help ensure that the technical evidence supporting our planned 510(k) is complete, traceable and robust.
The submission scope covers functionality of the Albus platform, which includes Albus Home hardware, embedded software, the web portals, including its associated backend/cloud infrastructure, including device-to-cloud interfaces.
We already have requirements, test cases and engineers who can execute tests. This is therefore not primarily a test-execution role. We need someone senior enough to review the complete verification evidence, identify what is missing or inadequate, explain what needs to change, and then work hands-on with the team to fix the gaps.
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.
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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.
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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.
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.
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