Navigation Systems V&V Engineering Manager | Hybrid

Johnson Johnson

Boston (MA)

Hybrid

USD 150,000 - 210,000

Full time

3 days ago
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Job summary

Johnson & Johnson is hiring a Navigation Systems Verification & Validation (V&V) Engineering Manager in a hybrid role based out of Raynham or Boston, MA. You will lead a team of engineers ensuring full V&V coverage and regulatory compliance for advanced navigation medical devices.

The role requires strong cross-functional collaboration with systems, hardware, software, clinical, and quality teams, and oversight of test facilities to guarantee robust verification and validation across product

Responsibilities

  • Lead a team of Verification & Validation and Integration Engineers to ensure navigation systems meet all defined subsystem- and system-level requirements.
  • Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable from user needs and system/subsystem requirements through verification and validation.
  • Define minimum testable requirements following design or requirement changes, applying a risk-based approach that considers essential performance and basic safety.
  • Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression strategies to ensure robust requirements coverage.
  • Prepare and deliver system-level V&V documentation, including summary reports and verification results.
  • Review and approve sub-system verification deliverables to ensure alignment with overall system requirements.
  • Design, validate, and implement test methods, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability, reproducibility.
  • Coordinate and manage engagement with external test facilities (e.g., NRTLs, EMC, and restricted-materials laboratories) to ensure full regulatory compliance and adherence to internal company policies.
  • Oversee the maintenance of navigation systems test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards; proactively identify and resolve issues to support uninterrupted testing and development workflows.
  • Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).
  • Support design transfer and product launch activities including complaints investigations.
  • Investigate and document non-conformances, deviations, and test failures, drive root cause analysis and corrective actions.
  • Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
  • Responsible for communicating business-related issues or opportunities to next management level

Job description

Johnson & Johnson is hiring a Navigation Systems Verification & Validation (V&V) Engineering Manager in a hybrid role based out of Raynham or Boston, MA. You will lead a team of engineers ensuring full V&V coverage and regulatory compliance for advanced navigation medical devices.

The role requires strong cross-functional collaboration with systems, hardware, software, clinical, and quality teams, and oversight of test facilities to guarantee robust verification and validation across product

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