Medical Device Verification & Validation Engineer

The Judge Group; Marlborough (MA); On-site; USD 75,000 - 90,000; Full time

Job summary

The Judge Group seeks a Verification & Validation Test Engineer in Marlborough, MA to design, build, and validate test methods for medical devices in an ISO 13485 and FDA QSR environment. You will execute V&V for electromechanical devices and disposables, develop test methods, document protocols and data, and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971.

This is a full-time permanent role with benefits like 401k, dental, vision, etc.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering.
• 1–3 years of engineering experience within the medical device or regulated industry.
• Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.
• Direct experience in planning and/or execution of Verification and Validation for complex electrotechnical devices.

Responsibilities

• Medical Device Testing: Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables.
• Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality.
• Documentation: Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions.
• Quality Compliance: Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
• Data Analysis: Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets.
• Communication: Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable.

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering

Job description

The Judge Group seeks a Verification & Validation Test Engineer in Marlborough, MA to design, build, and validate test methods for medical devices in an ISO 13485 and FDA QSR environment. You will execute V&V for electromechanical devices and disposables, develop test methods, document protocols and data, and ensure compliance with ISO 13485, FDA 21 CFR Part 820, and ISO 14971.

This is a full-time permanent role with benefits like 401k, dental, vision, etc.