Senior Medical Device Certification Engineer

6 hours ago


Cary, North Carolina, United States Eurofins GSC Poland Sp. z o. o. Full time
Job Overview

We are seeking a highly skilled Senior Medical Device Certification Engineer to join our team at Eurofins GSC Poland Sp. z o. o. as a Lead Product Safety Project Professional - Medical Engineering.

Salary and Benefits

The estimated annual salary for this position is approximately $110,000-$140,000, depending on experience. Our comprehensive benefits package includes excellent full-time benefits, including medical coverage, dental, and vision options, life and disability insurance, 401(k) with company match, paid vacation and holidays, and an exempt/salary position with a standard Monday-Friday schedule.

Job Description

In this role, you will be responsible for ensuring the compliance of medical devices with relevant standards and regulations. Your key responsibilities will include:

  • Serving as a customer technical contact and interpreting medical standards to apply requirements to products under investigation.
  • Creating and implementing test plans, conducting required tests in accordance with applicable standards, procedures, and documenting results.
  • Ensuring test equipment is calibrated or tested and operates properly.
  • Interface with and update the lab manager.
  • Reviewing files and reports prepared by other project engineers, including peer reviews.
  • Conducting preliminary design reviews.
  • Monitoring multiple projects.
  • Preparing certification reports and related documents.
Requirements and Qualifications

To be successful in this role, you will need:

  • A four-year engineering college degree in Biomedical or Electrical discipline preferred or three years progress towards four-year degree, or equivalent work experience.
  • Prior experience performing certification for medical devices at another test, inspection, and certification laboratory preferred but not required.
  • Ability to support department objectives and company goals.
  • Excellent teamwork and communication skills.
  • A positive, enthusiastic, and professional attitude.
  • Adherence to manager directives and maintaining a professional appearance and demeanor.
About Us

Eurofins GSC Poland Sp. z o. o. is a leading provider of testing, inspection, and certification services for medical devices. We are committed to delivering high-quality solutions that meet the evolving needs of our customers.



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