Medical Device Test & Validation Engineer

IPG Photonics; Marlborough (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

IPG Photonics in Marlborough, MA seeks a Test Engineer to design and validate test methods for electromechanical devices and single-use disposables in a regulated setting. You will plan verification activities, develop fixtures, and analyze data to inform design decisions.

The role requires 2–5 years in medical devices or regulated industries, with hands-on testing, MATLAB/Minitab skills, and knowledge of ISO 13485 and FDA QSR. On-site position in Massachusetts.

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 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

• Plan and 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.
• Conduct early-stage exploratory testing and characterization to support design inputs.
• Design, fabricate, and assemble custom test fixtures and automated equipment.
• Write and execute protocols and reports for test software and hardware.
• Author test protocols, data sheets, and final reports; assist manufacturing procedures and machine instructions.
• Ensure activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
• Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets.
• Present test findings to stakeholders and communicate risk and countermeasure insights.

Skills

Design verification

Test method development

Statistical analysis

Python / C

MATLAB

Education

Bachelor's degree in Mechanical/Electrical/Biomedical/Quality Engineering

Tools

MATLAB

Minitab

Job description

IPG Photonics in Marlborough, MA seeks a Test Engineer to design and validate test methods for electromechanical devices and single-use disposables in a regulated setting. You will plan verification activities, develop fixtures, and analyze data to inform design decisions.

The role requires 2–5 years in medical devices or regulated industries, with hands-on testing, MATLAB/Minitab skills, and knowledge of ISO 13485 and FDA QSR. On-site position in Massachusetts.