Verification Validation Lead

Key Responsibilities

• Author and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activities.
• Define the verification approach in alignment with the IEC 62304 software development lifecycle, scaled to the product's software safety classification (Class A/B/C).
• Establish verification scope, methods, acceptance criteria, entry/exit criteria, and resource and schedule estimates.
• Define and maintain requirements-to-test traceability, ensuring every requirement and risk control measure is verified.
• Risk-Based Verification: Integrate verification with the risk management process per ISO 14971, ensuring that risk control measures are verified for effectiveness and that residual risk acceptability is supported by objective evidence.
• Prioritize and scale test coverage according to risk, software safety class, and hazard analysis outputs.
• Verify that risk controls implemented in software are correctly traced, tested, and documented.
• Test Protocol Design & Execution: Design test protocols and test cases for unit, integration, software system, and overall system verification. Specify test environments, test data, tools, fixtures, and pass/fail criteria. Oversee protocol execution, review test records, and adjudicate anomalies and deviations.
• Manage the defect/anomaly lifecycle: triage, root cause support, regression strategy, and verification of fixes.
• Reviews & Technical Governance: Lead and facilitate design reviews, requirements reviews, test protocol reviews, and verification results reviews. Review verification deliverables for completeness, traceability, and audit-readiness. Serve as a gatekeeper at design milestones, providing objective verification evidence for design transfer and release decisions.
• Documentation & Compliance: Produce verification deliverables suitable for the Design History File (DHF) and regulatory submissions. Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU MDR. Support internal and external audits, notified body assessments, and regulatory questions related to verification.

Required Qualifications

• Bachelor's degree in engineering, computer science, or a related technical field (or equivalent experience).
• 8+ years in verification, V&V, in medical devices.
• Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk management).
• Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Device).
• Experience authoring verification plans and designing test protocols from requirements.
• Strong grasp of requirements traceability and design control processes.
• Experience leading technical reviews and producing audit-ready documentation.
• Excellent written communication; able to write protocols and reports that withstand regulatory review.
• Experience supporting regulatory submissions and notified body audits.