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Verification Lead

Karwell Technologies

  • Andover, MA
  • 30+ days ago

    Highlights

    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. Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU MDR.

    Numbers & Facts

    LocationAndover, MA

    Description

    Job Description:
    • 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.
    • 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.
    Requirements:
    • 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.

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