Lead, Navigation Systems V&V for MedTech Robotics

Johnson & Johnson MedTech; Raynham (MA); Hybrid; USD 117,000 - 201,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year

Holiday pay

Job summary

Johnson & Johnson MedTech 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 V&V and Integration Engineers to ensure navigation systems meet defined requirements and comply with FDA/ISO standards.

You will collaborate with systems, hardware, and software teams, develop V&V strategies, and manage external test facilities to ensure regulatory compliance and robust verification results.

Qualifications

• 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).
• Familiarity with test automation tools and scripting languages (Python, LabVIEW, MATLAB).
• Excellent technical writing and communication skills.

Responsibilities

• Lead a team of Verification & Validation and Integration Engineers to ensure navigation systems meet all defined subsystem-and system-level requirements.
• Collaborate with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable.
• Define minimum testable requirements following design or requirement changes, applying a risk-based approach.
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression strategies.
• Prepare and deliver system-level V&V documentation, including summary reports and verification results.
• Reviewing and approving 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 repeatability and reproducibility.
• Coordinate and manage engagement with external test facilities to ensure regulatory compliance and policy adherence.
• Oversee the maintenance of navigation systems test lab facilities and calibration.
• Ensure compliance with regulatory standards (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, drive root cause analysis and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
• Communicate business-related issues to next management level.
• Ensure personal and company compliance with all regulations and policies.

Skills

Systems engineering

Requirements management

Test automation

Python

Education

Bachelor’s or Master’s degree in biomedical/Systems/Electrical Engineering

Tools

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

Job description

Johnson & Johnson MedTech 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 V&V and Integration Engineers to ensure navigation systems meet defined requirements and comply with FDA/ISO standards.

You will collaborate with systems, hardware, and software teams, develop V&V strategies, and manage external test facilities to ensure regulatory compliance and robust verification results.