Senior Robotics V&V Engineer for Medical Devices

Jobtailor; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Jobtailor in Boston, MA seeks a dedicated V&V Engineer to lead verification and validation activities for medical devices. You will collaborate with Systems Engineering to ensure requirements clarity and traceability, develop test strategies, and prepare system-level verification documentation across the product lifecycle.

The role requires 3+ years in V&V for medical devices, familiarity with DOORS/Jama/Polarion, and proficiency in Python/LabVIEW/MATLAB for test automation.

Qualifications

• Bachelor's or master's degree required 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 preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.
• Strong understanding of systems engineering principles and product development lifecycle (V-model, waterfall, Agile).
• 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.
• CQE, CQA, Six Sigma a plus.
• Proficient in statistical methods for data analysis.

Responsibilities

• Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs through 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.
• Review sub-system verification deliverables to ensure alignment with overall system requirements.
• Design, validate, and implement test methods, including manual and automated test setups, ensuring repeatability and reproducibility.
• Oversee maintenance of robotics test lab facilities, calibration, servicing, and compliance with safety and quality standards.
• 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, deviations, and test failures; drive root cause and corrective actions.
• Interface with regulatory, quality, and manufacturing teams to support audits and inspections.
• Communicate business-related issues or opportunities to management.
• Follow all Company guidelines on Health, Safety and Environmental practices.
• Identify critical paths, bottlenecks, and risks; facilitate problem solving across R&D teams.
• Support project resource and schedule planning.

Skills

V&V engineering

Regulatory compliance

Requirements management

Test automation

Statistical analysis

Education

Bachelor's or Master's in Biomedical Engineering

Systems Engineering

Electrical Engineering

Tools

DOORS

Jama

Polarion

Python

LabVIEW

MATLAB

V&V Documentation

Embedded testing

Job description

Jobtailor in Boston, MA seeks a dedicated V&V Engineer to lead verification and validation activities for medical devices. You will collaborate with Systems Engineering to ensure requirements clarity and traceability, develop test strategies, and prepare system-level verification documentation across the product lifecycle.

The role requires 3+ years in V&V for medical devices, familiarity with DOORS/Jama/Polarion, and proficiency in Python/LabVIEW/MATLAB for test automation.