Medical Device Test Engineer – Verification & Validation

IPG Laser GmbH; Marlborough (MA); On-site; USD 75,000 - 87,000; Full time

Benefits offered by this job

401(k) matching

Health Insurance

Paid vacation

Job summary

IPG Photonics in Marlborough, MA seeks a Verification and Validation Test Engineer to design, build, and validate test methods for medical devices and disposables in an ISO 13485 and FDA QSR environment.

The role supports R&D through Production, performing verification activities, developing test methods, documenting protocols and reports, and analyzing data with statistics to inform design decisions.

Qualifications

• Bachelor's degree required in Mechanical, Electrical, Biomedical, or Quality Engineering.
• 1–3 years of engineering experience in medical device or regulated industry.
• Familiarity with ISO 13485, FDA QSR, ISO 14971 risk management.
• Experience planning/executing verification and validation for complex devices.
• Proficiency with data analysis tools (Excel, Python) or Minitab.

Responsibilities

• Execute verification and validation activities for medical devices and single-use disposables.
• Design, develop, validate and execute test methods to inform design decisions.
• Author test protocols, data sheets, and final reports; assist manufacturing procedures.

Skills

Data analysis

Statistical analysis

Communication

Education

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

Tools

Excel

Python

Minitab

Data acquisition systems

Job description

IPG Photonics in Marlborough, MA seeks a Verification and Validation Test Engineer to design, build, and validate test methods for medical devices and disposables in an ISO 13485 and FDA QSR environment.

The role supports R&D through Production, performing verification activities, developing test methods, documenting protocols and reports, and analyzing data with statistics to inform design decisions.