US_East | QA / Quality Engineer_L4

VnV Lead

Andover, MA

We are seeking a Verification (V&V) Lead to own the verification strategy for medical device products, ensuring software and system compliance with applicable regulatory standards, including FDA requirements and notified body audits. This is a hands-on technical leadership role that bridges engineering, quality, and regulatory affairs. The role involves defining verification strategy, driving risk-based testing, and mentoring verification engineers.

Top 5 Required Skillsets:

• Verification & Validation (V&V) leadership in medical device environments
• Strong working knowledge of IEC 62304 and ISO 14971 standards
• Experience with embedded systems, connected devices, or SaMD (Software as a Medical Device)
• Expertise in requirements traceability and test protocol design from requirements
• Experience supporting FDA / ISO 13485 / EU MDR audits and regulatory submissions

Key Responsibilities:

• Verification Strategy & Planning
• Develop and maintain the Verification Plan and Master V&V Plan across software, system, and subsystem levels
• Define verification approach aligned with IEC 62304 software lifecycle and safety classification (Class A/B/C)
• Establish scope, methods, acceptance criteria, entry/exit criteria, and estimation of resources and schedules
• Ensure end-to-end requirements-to-test traceability for all requirements and risk control measures
• Risk-Based Verification
• Integrate verification activities with ISO 14971 risk management processes
• Ensure risk control measures are verified and supported with objective evidence
• Prioritize testing based on risk levels, safety classification, and hazard analysis outputs
• Ensure proper traceability and validation of software-based risk controls
• Test Protocol Design & Execution
• Design test cases and protocols for unit, integration, software system, and system-level verification
• Define test environments, data, tools, fixtures, and pass/fail criteria
• Oversee execution of test protocols and review results, deviations, and anomalies
• Manage defect lifecycle including triage, root cause analysis support, and regression strategy
• Reviews & Technical Governance
• Lead design, requirements, and verification review meetings
• Ensure verification deliverables are complete, traceable, and audit-ready
• Act as gatekeeper for design milestones and release decisions based on verification evidence
• Documentation & Compliance
• Create verification documentation for Design History File (DHF) and regulatory submissions
• Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1, FDA 21 CFR 820, and EU MDR
• Support internal/external audits and regulatory inquiries
• Leadership
• Provide mentorship and technical guidance to verification engineers
• Collaborate with software, systems engineering, quality, and regulatory teams
• Drive continuous improvement in verification processes, automation, and metrics

Required Qualifications:

• Bachelor's degree in Engineering, Computer Science, or related technical field (or equivalent experience)
• 8+ years of experience in V&V within medical device or regulated environments
• Strong understanding of IEC 62304 software lifecycle and ISO 14971 risk management
• Experience in embedded systems, connected devices, or SaMD
• Proven experience writing verification plans and test protocols from requirements
• Strong knowledge of requirements traceability and design control processes
• Experience leading technical reviews and audit-ready documentation
• Excellent written communication skills for regulatory-grade documentation

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.