Medical Device Verification & Validation Engineer

IPG Photonics; Marlborough (MA); On-site; USD 93,000 - 123,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Employee Stock Purchase Plan

Tuition Reimbursement Program

Job summary

IPG Photonics in Marlborough, MA, seeks a Test Engineer to design, validate, and execute verification activities for medical devices in an ISO 13485 and FDA QSR environment. You will collaborate with R&D and production teams to ensure robust test methods and compliant documentation.

The role requires 2–5 years in a regulated medical device setting, experience with DV/IV testing, TMV validation, and data analysis using MATLAB or Minitab.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering (or 3-4 years of trade exp).
• 2–5 years engineering experience in medical device or regulated industry.
• Knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management.
• Experience planning and executing Verification and Validation for complex electromechanical devices.
• Experience writing Equipment IQ/OQ/PQ and TMV validation.

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.
• 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 relevant stakeholders and communicate risk insights.

Skills

Data acquisition

MATLAB

Minitab

Python

C

Tensile testing

Gauges

Sensors

Education

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

Tools

SolidWorks

CAD

Job description

IPG Photonics in Marlborough, MA, seeks a Test Engineer to design, validate, and execute verification activities for medical devices in an ISO 13485 and FDA QSR environment. You will collaborate with R&D and production teams to ensure robust test methods and compliant documentation.

The role requires 2–5 years in a regulated medical device setting, experience with DV/IV testing, TMV validation, and data analysis using MATLAB or Minitab.