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. Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society. Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits. Position Summary 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.

Key Responsibilities Verification Testing:

Plan and execute Design Verification and Validation activities for com plex 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

Required Qualifications Education:

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

Regulations:

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

Lab Skills:

Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors Preferred Qualifications Experience with endoscopic surgical laser systems Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow 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 Able to read schematics Experience with rapid prototyping (SLA, FDM, CNC)