Principal Software & Systems QA Test Engineer - Medical Devices (Contract) in Oxford

Description

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.

About the role

Albus Health is seeking an experienced Principal Software & Systems QA Test Engineer for a short-term contract focused on strengthening technical verification evidence for software-containing medical devices. You will work closely with Engineering and QARA to review and improve requirements, verification approaches, acceptance criteria, objective test evidence, risk-control verification, traceability and reports. The work supports our regulated medical-device development and FDA submission activities.

This is a hands-on technical verification and design assurance role, not primarily a regulatory affairs, QMS implementation or routine test-execution position.

Success means a risk-prioritised assessment of the existing verification package, material gaps addressed or clearly dispositioned, and coherent, traceable and defensible verification evidence. The role is focused on improving an existing programme rather than establishing a new test-execution function.

Key responsibilities

• Review and improve system and software requirements, interface requirements and acceptance criteria for clarity, completeness, technical testability and traceability.
• Critically assess verification plans, protocols/test cases, execution records, objective evidence, deviations and formal verification reports; personally improve documentation where appropriate.
• Assess verification coverage across embedded software, hardware/software interactions, device-to-cloud interfaces and relevant web/backend/cloud functionality.
• Assess and strengthen end-to-end traceability between requirements, hazards and risk controls, verification methods, results, anomalies and conclusions.
• Apply IEC 62304, ISO 13485, ISO 14971 and applicable FDA expectations pragmatically to technical verification evidence.
• Identify and prioritise verification gaps by patient safety, risk-control coverage, intended use, technical impact and submission readiness; distinguish documentary remediation from additional testing needs.
• Work directly with engineers and testers to rewrite or improve requirements, test protocols, acceptance criteria, traceability records and reports, while retaining appropriate engineering ownership.
• Assess anomalies, deviations, unresolved defects and regression implications; ensure documented, risk-based disposition.
• Coach and mentor software engineers and test colleagues in producing clear, proportionate, objective verification evidence for regulated medical devices.
• Provide Engineering and QARA leadership with an independent technical assessment of verification readiness, material gaps and residual risks.
• Collaborate with the Head of QARA, who retains overall quality and regulatory authority for submissions.

Requirements

Essential experience and capabilities

• Substantial recent, hands-on software and systems verification or design assurance experience for regulated medical devices, ideally at Senior, Lead or Principal level.
• Strong practical knowledge of IEC 62304 and experience applying it 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.
• Demonstrable experience personally reviewing and remediating existing requirements, verification protocols, acceptance criteria, objective test evidence, traceability and formal verification reports—not solely overseeing their preparation.
• Experience with embedded software/firmware verification in medical devices and hardware/software interactions.
• Experience with connected devices and web/cloud software; able to challenge verification of interfaces and end-to-end behaviour across device, cloud/backend and web portal.
• Ability to judge whether verification methods and objective evidence actually demonstrate the specified requirements and risk controls, rather than merely confirming that tests have been executed.
• Strong technical writing and documentation skills.
• Ability to work independently, challenge constructively and communicate gaps clearly to engineering and quality/regulatory stakeholders.
• Pragmatic, hands-on approach to assessing an existing evidence baseline, prioritising gaps and delivering tangible remediation within a short engagement.

FDA experience

Direct experience supporting FDA 510(k) submissions for software-containing medical devices is strongly preferred, especially where the candidate personally prepared, reviewed or remediated verification evidence. Candidates with exceptional medical-device software/systems verification experience and sound FDA knowledge will also be considered.

Desirable experience

• Experience of multiple FDA submissions or FDA questions relating to verification/software documentation.
• Experience integrating system-level traceability to specialist verification evidence supplied by hardware, cybersecurity or external testing teams; specialist test-method expertise is not required.
• Familiarity with medical-device cybersecurity verification and associated evidence interfaces; specialist cybersecurity work will be led separately.
• Experience in small or scaling medical-device companies where responsibilities cross traditional functional boundaries.
• Experience mentoring software engineers or test engineers who are new to medical-device verification.

The kind of person who will thrive in this role

You combine strong technical verification judgement with practical experience improving imperfect engineering evidence. You can explain why a requirement, test or report is inadequate, the risk that creates and the minimum proportionate work needed to resolve it. You are equally comfortable discussing verification strategy with leadership and working alongside an engineer to improve a requirement, protocol or test record.

Benefits

Working arrangements

• Initial 3-month contract, with potential extension to approximately 6 months.
• Start as soon as possible, ideally within weeks.
• Predominantly remote once established in the role.
• Office attendance expected during initial onboarding and periodically thereafter.
• UK-based candidates are preferred, but candidates based further away may be considered where practical travel and effective collaboration are possible.