Navigation Systems V&V Engineering Lead (Robotics)

Johnson & Johnson Innovation; Massachusetts; Híbrido; USD 117 000 - 201 000; Tempo integral

Resumo da oferta

Johnson & Johnson is hiring a Navigation Systems Verification & Validation Engineering Manager in a hybrid role based at Raynham or Boston, MA. You will lead a team of V&V and integration engineers, ensuring risk-based, testable requirements are met and regulatory obligations are satisfied.

You will collaborate across systems, hardware, software, clinical, and quality teams to deliver robust verification and validation for navigation devices, supporting FDA/ISO compliance and product launches.

Qualificações

• Bachelor’s or master’s degree in biomedical engineering, systems engineering, electrical engineering, or related field.
• 7+ years of experience in V&V engineering within the medical device industry.
• Strong understanding of systems engineering principles and product development lifecycle.
• Experience with requirements management tools (DOORS, Jama, Polarion) and test automation tools (Python, LabVIEW, MATLAB).
• Excellent technical writing and communication skills.

Responsabilidades

• Lead a team of Verification & Validation and Integration Engineers to meet subsystem and system requirements.
• Collaborate with systems, hardware, and software teams to ensure testable, traceable requirements.
• Define minimum testable requirements following design changes with a risk-based approach.
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices.
• Prepare and deliver system-level V&V documentation, including summary reports.
• Review and approve subsystem verification deliverables for alignment with requirements.
• Design, validate, and implement test methods, including manual and automated setups.
• Coordinate engagement with external test facilities to ensure regulatory compliance.
• Oversee navigation systems test lab facilities and maintain equipment calibration and safety standards.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971.
• Support design transfer and product launch activities including investigations.
• Investigate non-conformances, drive root cause analysis and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
• Communicate business-related issues or opportunities to next management level.
• Ensure adherence to Health, Safety and Environmental practices.

Conhecimentos

Computer Programming

Consulting

Critical Thinking

Data‑Driven Decision Making

Data Science

Developing Others

Inclusive Leadership

Industry Analysis

Innovation

Leadership

Manufacturing Technologies

Product Knowledge

Prototyping

Quality Assurance (QA)

Research and Development

Robotic Automation

SAP Product Lifecycle Management

Team Management

Formação académica

Bachelor’s or Master’s degree in Biomedical Engineering or related field

Ferramentas

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

Descrição da oferta de emprego

Johnson & Johnson is hiring a Navigation Systems Verification & Validation Engineering Manager in a hybrid role based at Raynham or Boston, MA. You will lead a team of V&V and integration engineers, ensuring risk-based, testable requirements are met and regulatory obligations are satisfied.

You will collaborate across systems, hardware, software, clinical, and quality teams to deliver robust verification and validation for navigation devices, supporting FDA/ISO compliance and product launches.