Test Engineer

IPG Photonics • Marlborough, MA

9d

About The Position

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

The engineer tests complex electromechanical devices and single-use disposables, develops and executes test methods to inform design decisions and verify system functionality, and produces protocols, data sheets, reports, and manufacturing documentation. The role also applies statistical methods to test data and communicates findings, risks, and potential countermeasures to stakeholders.

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.

Benefits

• Competitive benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level