Senior Medical Device Verification Engineer - FDA/ISO Ready

Albus Health; Oxford; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Albus Health in Oxford is seeking a senior medical-device verification engineer for an initial three-month contract with potential extension. You will strengthen verification evidence and regulatory documentation for FDA submissions.

You will review requirements, test plans, and traceability, identify gaps, and work with engineering, quality and regulatory teams to improve evidence. UK-based candidates preferred; some remote work possible.

Qualifications

• Substantial hands-on verification experience with regulated medical devices at senior/lead/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.

Responsibilities

• 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.

Skills

Verification experience

IEC 62304

ISO 13485

ISO 14971

FDA knowledge

Technical writing

Mentoring

Embedded software

Hardware–software interaction

Regulatory submissions

Job description

Albus Health in Oxford is seeking a senior medical-device verification engineer for an initial three-month contract with potential extension. You will strengthen verification evidence and regulatory documentation for FDA submissions.

You will review requirements, test plans, and traceability, identify gaps, and work with engineering, quality and regulatory teams to improve evidence. UK-based candidates preferred; some remote work possible.