Test Validation Engineering

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life.

Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
The Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This Role reports to Quality Management, supporting various project teams in different stages of project maturity from R&D through Production.

Verification Testing: 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
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
Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable
Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
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
Verification & Validation: Direct experience in planning and execution of Verification and Validation for complex electrotechnical devices
Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, or statistical software like Minitab
Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors
Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
SolidWorks or CAD proficiency for mechanical fixture design
Experience coding data acquisition using Python / C, able to troubleshoot basic code
Experience with rapid prototyping (SLA, FDM, CNC)