Verification & Validation Lead

Contract Andover, MA Job Description Key Responsibilities Verification Strategy & Planning

• 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.

Leadership

• Mentor and provide technical direction to verification engineers.
• Coordinate cross-functionally with software development, systems engineering, quality, and regulatory affairs.
• Continuously improve verification methods, tooling, automation, and metrics.

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.