Principal Medical Device Verification Engineer

Albus Health

. Review system, hardware and software requirements for clarity, completeness, testability and suitability for verification .

Posted 10/3/2026contractOxford • United KingdomLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in verification of regulated medical devices, applying IEC 62304, ISO 13485, and ISO 14971 standards. Proficient in technical writing, risk assessment, and mentoring within FDA-regulated environments.

Highest-signal resume keywords

Verification Experience With Regulated Medical DevicesApplication Of IEC 62304ISO 13485 Quality Management SystemFDA 510(k) Submission SupportTechnical Writing And Documentation Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Verification PlansTest ProtocolsTraceability MatricesRisk-Based VerificationEmbedded Software VerificationHardware/Software InteractionsConnected DevicesWeb/Cloud SoftwareCybersecurity VerificationRegulatory Risk Assessment

Soft Skills

Constructive ChallengeClear CommunicationMentoringHands-On ApproachConfidence In Judgement

Industry Keywords

FDA RegulationsIEC 62304ISO 13485ISO 14971510(k) SubmissionMedical Device VerificationCybersecurity ExpectationsElectrical SafetyEMC/Radio ComplianceSmall Medical-Device Companies

Tech Stack

Tools & technologies

CloudCyber Security

About the role

Key responsibilities & impact

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, backend/cloud and device-to-cloud functionality
Apply IEC 62304, ISO 13485, ISO 14971 and relevant FDA expectations to technical evidence
Identify regulatory or technical risks in the 510(k) submission and define proportionate remediation
Improve or rewrite requirements, test protocols, reports, traceability records and other technical documentation
Review specialist evidence including hardware safety, radio, manufacturing and cybersecurity deliverables
Ensure deviations, anomalies and unresolved issues are assessed, documented and dispositioned
Coach software engineers and testing colleagues on FDA-regulated medical-device verification evidence
Provide a technical view on verification readiness while working with the Head of QARA, who retains overall quality and regulatory authority

Requirements

What you’ll need

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
Confidence to challenge constructively, make risk-based judgements and explain clearly why evidence is or is not adequate
Hands-on approach 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 if direct 510(k) experience is limited
Experience with multiple FDA submissions or responding to FDA questions relating to software or verification documentation is useful
Experience integrating electrical safety, EMC/radio, manufacturing or other specialist hardware evidence into a device verification package is useful
Familiarity with medical-device cybersecurity verification and FDA cybersecurity expectations is useful
Experience in small or scaling medical-device companies is useful
Experience mentoring software or test engineers new to medical-device verification is useful
Ability to start as soon as possible, ideally within weeks
UK-based preferred; practical travel and effective collaboration required for candidates based further away

Benefits

Comp & perks

Initial three-month contract with potential extension to 6+ months
Most work can be performed remotely once established
UK-based candidates preferred; candidates based further away may be considered where practical travel and effective collaboration are possible