Verification Lead

About the role

We are seeking a Verification Lead to own the verification strategy for our medical device products and ensure that our software and systems meet their specified requirements and in compliance with applicable regulatory standards (FDA and notified body audits). This is a hands-on technical leadership role that bridges engineering, quality, and regulatory affairs. You will design verification protocols, drive risk-based test coverage, and mentor a team of verification engineers.

Responsibilities

• Verification Strategy & Planning: Author and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activities.
• Verification Strategy & Planning: 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).
• Verification Strategy & Planning: Establish verification scope, methods, acceptance criteria, entry/exit criteria, and resource and schedule estimates.
• Verification Strategy & Planning: 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.
• Risk-Based Verification: Prioritize and scale test coverage according to risk, software safety class, and hazard analysis outputs.
• Risk-Based Verification: 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.
• Test Protocol Design & Execution: Specify test environments, test data, tools, fixtures, and pass/fail criteria.
• Test Protocol Design & Execution: Oversee protocol execution, review test records, and adjudicate anomalies and deviations.
• Test Protocol Design & Execution: 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.
• Reviews & Technical Governance: Review verification deliverables for completeness, traceability, and audit-readiness