Navigation Systems V&V Engineering Manager

Johnson & Johnson

. Lead a team of Verification & Validation and Integration Engineers .

Posted 11/11/2026full-timeRaynham • Massachusetts • United StatesSeniorLead💰 $120,000 - $207,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Verification and Validation (V&V) engineering for complex medical devices, with a strong focus on compliance with FDA regulations and ISO standards. Proficient in developing V&V strategies, managing requirements, and utilizing test automation tools to ensure product quality and reliability.

Highest-signal resume keywords

Verification And Validation EngineeringFDA 21 CFR Part 820 ComplianceRequirements Management ToolsTest Automation ToolsStatistical Methods For Analyzing Data

ATS Keywords

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Hard Skills

V&V StrategiesTestable Requirements DefinitionRisk-Based ApproachRoot Cause AnalysisSample Size CalculationSystems Engineering PrinciplesProduct Development LifecycleEmbedded Systems KnowledgeFirmware/Software TestingElectromechanical Systems Testing

Soft Skills

Technical WritingCommunication SkillsProblem SolvingCollaboration

Tools & Technologies

DOORSJamaPolarionPythonLabVIEWMATLAB

Certifications & Qualifications

CQECQASix Sigma

Industry Keywords

Medical Device IndustryClass II Medical DevicesClass III Medical DevicesSurgical RoboticsSurgical Navigation TechnologiesISO 13485IEC 60601ISO 14971

Tech Stack

Tools & technologies

Python

About the role

Key responsibilities & impact

Lead a team of Verification & Validation and Integration Engineers
Collaborate with systems engineering, hardware, and software teams to define testable and traceable requirements
Define minimum testable requirements after design or requirement changes using a risk-based approach
Develop and execute V&V strategies and master system test plans for complex medical devices
Oversee investigational, integration, reliability, and formal verification and validation testing
Prepare and deliver system-level V&V documentation, summary reports, and verification results
Review and approve subsystem verification deliverables
Design, validate, and implement manual and automated test methods
Coordinate external test facilities, including NRTLs, EMC, and restricted-materials laboratories
Oversee navigation systems test lab maintenance, calibration, servicing, and compliance
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971, and other applicable standards
Support design transfer, product launch activities, and complaints investigations
Investigate non-conformances, deviations, and test failures; drive root cause analysis and corrective actions
Interface with regulatory, quality, and manufacturing teams for audits and inspections
Communicate business-related issues or opportunities to the next management level
Ensure compliance with health, safety, environmental, federal, state, local, and company requirements
Identify critical paths, address bottlenecks and risks, and facilitate problem solving across R&D teams
Support project resource and schedule planning
Perform other duties as assigned

Requirements

What you’ll need

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, including V-model, waterfall, and Agile
Experience with requirements management tools such as DOORS, Jama, or Polarion
Familiarity with test automation tools and scripting languages such as Python, LabVIEW, or MATLAB
Excellent technical writing and communication skills
Experience with Class II or Class III medical devices preferred
Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus
Experience in surgical robotics or surgical navigation technologies is a major plus
Certification in CQE, CQA, or Six Sigma is a plus
Proficient in sample size calculation and statistical methods for analyzing data

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Reasonable accommodation for individuals with disabilities
Affirmative Action and Equal Opportunity Employer