Medical Device Verification & Validation Test Engineer

ipgjobs; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

IPG Photonics in Marlborough, MA seeks a Test Engineer to design, execute, and validate test methods for medical device verification and validation in a regulated environment. You will support R&D through production with hands-on testing and data-driven decision making.

The role emphasizes creating robust test fixtures, protocols, and reports, ensuring compliance with ISO 13485 and FDA standards while applying statistical techniques to test datasets and present findings to cross-functional teams.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience.
• 2–5 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 execution of Verification and Validation for complex electrotechnical devices.
• Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV).
• Proficiency with data acquisition systems and analysis tools like MATLAB or Minitab.
• Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors.

Responsibilities

• Verification Testing: Plan and 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.
• Research & Development: Conduct early-stage exploratory testing and characterization to support design inputs.
• Equipment Development: Design, fabricate, and assemble custom test fixtures and automated equipment.
• Equipment Validation: Write and execute protocols and reports for test software and hardware.
• 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.

Skills

Verification & Validation

Data Analysis

Lab Skills

Regulatory knowledge

Education

Bachelor's degree or equivalent in Engineering

Tools

MATLAB

Minitab

Data acquisition systems

Python

C

Job description

IPG Photonics in Marlborough, MA seeks a Test Engineer to design, execute, and validate test methods for medical device verification and validation in a regulated environment. You will support R&D through production with hands-on testing and data-driven decision making.

The role emphasizes creating robust test fixtures, protocols, and reports, ensuring compliance with ISO 13485 and FDA standards while applying statistical techniques to test datasets and present findings to cross-functional teams.