Test Engineer

IPG Photonics•Marlborough, MA

About The Position

The Verification and Validation Test Engineer designs, builds, and validates test methods for verification and validation testing of medical devices and disposables in an ISO 13485- and FDA QSR-compliant environment. The role reports to Quality Management and supports project teams across different stages of maturity, from R&D through Production.

Requirements

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 planning and/or executing Verification and Validation for complex electrotechnical devices.
Proficiency with data acquisition systems and analysis tools such as Excel and Python, or statistical software such as Minitab.
Hands-on experience using mechanical test equipment such as tensile testers, gauges, and sensors.

Nice To Haves

Experience with endoscopic surgical laser systems.
Experience supporting Design Verification activities for complex medical systems.
Experience working with mixed hardware and software systems.
Experience preparing technical documentation for regulatory submissions.
Experience using Minitab, Linux, and Python.

Responsibilities

Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables.
Design, develop, validate, and execute test methods to inform design decisions and verify system functionality.
Author test protocols, data sheets, and final reports; author or assist with manufacturing procedures and machine instructions.
Ensure activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
Apply statistical techniques such as ANOVA, Gage R&R, and capability analysis to test datasets.
Present test findings to relevant stakeholders and communicate risk and countermeasure insights as applicable.