VnV Lead - Verification & Validation Lead

Job Title: VnV Lead - Verification & Validation Lead

Location: Andover, MA - Onsite Role

Duration: 12 Month with extension or possible Contract-To-Hire

Job Description: SDT1OK - Verification & Validation Lead – 5 Days a Week Onsite Role from Day 1 in Andover, MA –

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 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

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Key Responsibiliti

esVerification Strategy & Planni

• ngAuthor and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activitie
• s.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 estimate
• s.Define and maintain requirements-to-test traceability, ensuring every requirement and risk control measure is verifie
• d.Risk-Based Verificati
• onIntegrate 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 evidenc
• e.Prioritize and scale test coverage according to risk, software safety class, and hazard analysis output
• s.Verify that risk controls implemented in software are correctly traced, tested, and documente
• d.Test Protocol Design & Executi
• onDesign test protocols and test cases for unit, integration, software system, and overall system verificatio
• n.Specify test environments, test data, tools, fixtures, and pass/fail criteri
• a.Oversee protocol execution, review test records, and adjudicate anomalies and deviation
• s.Manage the defect/anomaly lifecycle: triage, root cause support, regression strategy, and verification of fixe
• s.Reviews & Technical Governan
• ceLead and facilitate design reviews, requirements reviews, test protocol reviews, and verification results review
• s.Review verification deliverables for completeness, traceability, and audit-readines
• s.Serve as a gatekeeper at design milestones, providing objective verification evidence for design transfer and release decision
• s.Documentation & Complian
• ceProduce verification deliverables suitable for the Design History File (DHF) and regulatory submission
• s.Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU MD
• R.Support internal and external audits, notified body assessments, and regulatory questions related to verificatio
• n.Leadersh
• ipMentor and provide technical direction to verification engineer
• s.Coordinate cross-functionally with software development, systems engineering, quality, and regulatory affair
• s.Continuously improve verification methods, tooling, automation, and metric

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Required Technologies and Skill

• s: Bachelor's degree in engineering, computer science, or a related technical field (or equivalent experienc
• e).8 years in verification, V&V, in medical devic
• es.Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk managemen
• t).Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Devic
• e).Experience authoring verification plans and designing test protocols from requiremen
• ts.Strong grasp of requirements traceability and design control process
• es.Experience leading technical reviews and producing audit-ready documentati
• on.Excellent written communication; able to write protocols and reports that withstand regulatory revi
• ew.Experience supporting regulatory submissions and notified body audi