Test Engineer

IPG Medical; Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

IPG Medical is seeking a Test Engineer to design and validate test methods for medical devices and disposables in an ISO 13485 and FDA QSR environment. You will plan verification activities, develop test fixtures, and analyze data to inform design decisions.

The role requires 2–5 years in the medical device field, strong data analysis skills (MATLAB/Minitab), and hands-on lab experience with precision testing equipment. Collaboration with R&D and production is essential.

Qualifications

• Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering (or 3–4 years of equivalent trade experience).
• 2–5 years of engineering experience in medical devices or regulated industry.
• Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.
• Experience planning and executing Verification and Validation for complex electrotechnical devices.
• Experience writing and executing Equipment IQ/OQ/PQ and TMV.
• Proficiency with data acquisition systems and analysis tools like MATLAB or Minitab.
• Hands-on experience with mechanical test equipment (tensile testers, gauges, sensors).
• Preferred: endoscopic laser systems, surgical fluid handling components, CAD proficiency, and rapid prototyping.

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; support manufacturing procedures and machine instructions.
• Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
• Apply statistical techniques (ANOVA, Gage R&R, capability analysis) to test datasets.
• Present test findings to stakeholders and communicate risk and countermeasure insights.

Skills

Analytical thinking

Documentation

Communication

Problem solving

Education

Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering

Tools

MATLAB

Minitab

Data acquisition systems

SolidWorks

Job description

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 or Engineering 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)