Senior Robotics V&V Engineer – Orthopaedics

Antler; Boston (MA); On-site; USD 92,000 - 148,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson's Orthopaedics team in Boston, MA, is seeking a Senior Robotics Verification & Validation (V&V) Engineer to ensure robotic medical devices meet requirements, are safe, effective, and regulatory-compliant for clinical use.

You will plan, execute, and document comprehensive V&V activities in line with FDA, ISO 13485 and IEC standards, collaborating with systems, software, hardware, robotics, and quality teams across the product lifecycle.

Qualifications

• Bachelor's or master's degree in biomedical engineering, Systems Engineering, Electrical Engineering, or related field.
• 3+ years of experience in V&V engineering within the medical device industry.
• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
• Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
• Excellent technical writing and communication skills.
• Certification in CQE, CQA, or Six Sigma is a plus.
• Proficient in sample size calculation and statistical methods for analyzing data.

Responsibilities

• Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs to verification and validation.
• Define minimum testable requirements post-change (risk-based, essential performance, basic safety).
• Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression plans.
• 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 they are suitable for verifying product requirements.
• Oversee the maintenance of robotics test lab facilities, ensuring calibration and safety compliance.
• Ensure regulatory compliance (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.
• Communicate business-related issues or opportunities to management; ensure adherence to health, safety, and environmental guidelines.
• Identify critical paths, address bottlenecks, and facilitate problem solving across R&D teams.
• Support project resource and schedule planning.

Skills

V&V engineering

Regulatory knowledge

Embedded systems

Testing & QA

Requirements analysis

Scripting languages

Excellent technical writing

MBSE

Statistical methods

Quality systems

Education

Bachelor's or master's in biomedical engineering or related field

Tools

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

Job description

Johnson & Johnson's Orthopaedics team in Boston, MA, is seeking a Senior Robotics Verification & Validation (V&V) Engineer to ensure robotic medical devices meet requirements, are safe, effective, and regulatory-compliant for clinical use.

You will plan, execute, and document comprehensive V&V activities in line with FDA, ISO 13485 and IEC standards, collaborating with systems, software, hardware, robotics, and quality teams across the product lifecycle.