VnV Lead - Verification Lead [Verification & Validation Lead)

Hi, we are hiring for Verification & Validation Lead for location Andover, MA/Onsite Role please go through the requirement and reply with suitable resumes

VnV Lead - Verification Lead [Verification & Validation Lead

)Location: Andover, MA/Onsite Rol

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Role and Responsibilities: 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 comply 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 engineer

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Key Responsibilit

• iesVerification Strategy & Plann
• ingAuthor and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activiti
• es.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 estimat
• es.Define and maintain requirements-to-test traceability, ensuring every requirement and risk control measure is verifi
• ed.Risk-Based Verificat
• ionIntegrate 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 eviden
• ce.Prioritize and scale test coverage according to risk, software safety class, and hazard analysis outpu
• ts.Verify that risk controls implemented in software are correctly traced, tested, and document
• ed.Test Protocol Design & Execut
• ionDesign test protocols and test cases for unit, integration, software system, and overall system verificati
• on.Specify test environments, test data, tools, fixtures, and pass/fail criter
• ia.Oversee protocol execution, review test records, and adjudicate anomalies and deviatio
• ns.Manage the defect/anomaly lifecycle: triage, root cause support, regression strategy, and verification of fix
• es.Reviews & Technical Governa
• nceLead and facilitate design reviews, requirements reviews, test protocol reviews, and verification results revie
• ws.Review verification deliverables for completeness, traceability, and audit-readine
• ss.Serve as a gatekeeper at design milestones, providing objective verification evidence for design transfer and release decisio
• ns.Documentation & Complia
• nceProduce verification deliverables suitable for the Design History File (DHF) and regulatory submissio
• ns.Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU M
• DR.Support internal and external audits, notified body assessments, and regulatory questions related to verificati
• on.Leaders
• hipMentor and provide technical direction to verification enginee
• rs.Coordinate cross-functionally with software development, systems engineering, quality, and regulatory affai
• rs.Continuously improve verification methods, tooling, automation, and metri

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Required Technologies and Ski

• lls:Bachelor's degree in engineering, computer science, or a related technical field (or equivalent experien
• ce).8 years in verification, V&V, in medical devi
• ces.Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk manageme
• nt).Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Devi
• ce).Experience authoring verification plans and designing test protocols from requireme
• nts.Strong grasp of requirements traceability and design control proces
• ses.Experience leading technical reviews and producing audit-ready documentat
• ion.Excellent written communication; able to write protocols and reports that withstand regulatory rev