11 – 50 Angajați
Sponsor pentru viza de lucrător calificatAsistență medicalăBiotehnologieIndustria prelucrătoareAlbus Health dezvoltă tehnologie de monitorizare la distanță, fără contact, pentru studii clinice și cercetare în domeniul sănătății. Dispozitivul său Albus Home RD monitorizează pasiv pacienții în propriile locuințe, în timpul somnului, captând măsurători fiziologice precum frecvența respiratorie și tusea, alături de date despre mediu, inclusiv calitatea aerului și umiditatea. Datele rezultate sprijină cercetarea și îngrijirea clinică pentru afecțiuni respiratorii precum astmul și boala pulmonară obstructivă cronică, permițând în același timp monitorizarea pacienților într-un mod mai puțin intruziv. Albus Health activează la intersecția dintre sănătate, biotehnologie și producție și are o echipă de 11–50 de angajați.
Principal Medical Device Verification Engineer – Albus Health, Oxford Hybrid
Lead verification of Albus Health’s hardware, software and cloud systems, building the evidence required for regulated medical-device development. Support FDA 510(k) readiness for its contactless clinical-trial health platform.
Descriere
- Evaluate system, hardware and software requirements for clarity, completeness, testability and verification suitability
- Review verification plans, protocols, test cases, acceptance criteria, execution records, objective evidence, anomalies and formal reports
- Evaluate traceability from requirements, hazards and risk controls through verification activities, results and reports
- Assess verification coverage across hardware, embedded software, MyAlbus, backend and cloud services, and device-to-cloud functions
- Apply IEC 62304, ISO 13485, ISO 14971 and applicable FDA expectations when evaluating technical evidence
- Identify regulatory and technical risks in the 510(k) submission and establish proportionate corrective actions
- Improve or rewrite requirements, test protocols, reports, traceability records and related technical documentation
- Review specialist evidence covering hardware safety, radio, manufacturing and cybersecurity
- Ensure deviations, anomalies and unresolved issues are evaluated, documented and formally dispositioned
- Coach software engineers and test colleagues in producing evidence for FDA-regulated medical-device verification
- Provide technical input on verification readiness while working with the Head of QARA, who retains overall quality and regulatory authority
Cerințe
- Extensive hands-on verification experience with regulated medical devices, preferably at senior, lead or principal level
- Practical experience applying IEC 62304 to medical devices that include software
- Strong experience operating within an ISO 13485 quality management system
- Working knowledge of ISO 14971 and risk-based verification, including verification of risk controls
- Experience improving requirements, test protocols, objective evidence, traceability matrices and verification reports
- Experience verifying embedded software or firmware and hardware-software interactions
- Experience with connected devices and web or cloud software, including device, backend and web-application interfaces
- Excellent technical writing and documentation ability
- Able to challenge constructively, make risk-based decisions and explain whether evidence is adequate
- Hands-on working style suited to a small, fast-moving company, including detailed remediation and mentoring
- Direct experience supporting FDA 510(k) submissions for software-containing medical devices is strongly preferred
- Strong FDA knowledge where direct 510(k) experience is limited
- Experience with multiple FDA submissions or responses to FDA questions about software or verification documentation is useful
- Experience incorporating electrical safety, EMC or radio, manufacturing or other specialist hardware evidence into device verification packages is useful
- Familiarity with medical-device cybersecurity verification and FDA cybersecurity expectations is useful
- Experience in small or growing medical-device companies is useful
- Experience mentoring software or test engineers who are new to medical-device verification is useful
- Able to start as soon as possible, ideally within weeks
- UK-based candidates are preferred; candidates farther away must be able to travel practically and collaborate effectively
Beneficii
- Three-month initial contract with potential extension beyond six months
- Most work can be completed remotely after onboarding
- UK-based candidates are preferred, while candidates farther away may be considered if practical travel and effective collaboration are possible