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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

System Verification Engineer

Job Summary

The System Verification Engineer is responsible for system level test activities during the development of new medical devices, and for conducting verification and validation campaigns. He/She is also in charge of continuously improving V&V methods and tools in order to optimize testing activities and ensure testing coverage.

Position Responsiblilities

  1. Review Customer, Product and Subsystem requirements to ensure consistency, coverage, traceability and testability.
  2. Conduct impact analysis and evaluate which compliance evidences need to be reassessed or provided during design change.
  3. Participate in verification strategy that ensures full requirement coverage, defect detectability, optimize time and resources.
  4. Write verification and validation protocols
  5. Organize and develop exploratory, integration and reliability testing.
  6. Compile data and write test reports.
  7. Develop automated tests to accelerate testing, optimize coverage and repeatability.
  8. Work with V&V Architect to ensure availability of resources, tools and test samples for verification campaigns.
  9. Participate in mechanical, electrical and software design reviews to ensure testability.
  10. Identify strengths and weaknesses, and propose short term quick wins and long-term improvement plans with formalized business cases.
  11. Participate in validation and usability testing (formative and summative) ; conduct testing with end users, collect and formalize relevant feedback.
  12. Create and use performance indicators to drive product quality during the development phase.

Position Requirements

  1. MS with 5+ years of experience, or BS and 7+ years of experience in relevant technical disciplines.
  2. Experience in the development of medical devices or other highly regulated industry.
  3. Experience with Design Verification and Validation activities.
  4. Ability to design and setup automated test benches.
  5. Experience with automated test bench programming (i.e. Python, Labview)
  6. Experience with automated test bench GAMP5 validation is a plus.
  7. Strong knowledge of sample size determination principles.
  8. Familiarity with a statistical software tool is a plus (i.e. Minitab).
  9. Familiarity with stress testing, including accelerated ageing and transit testing.
  10. Excellent understanding of design control processes as defined per ISO13485 and FDA 21 CFR Part 820.
  11. Familiarity with risk management ISO 14971.
  12. Good interpersonal skills with demonstrated ability to work in an international environment.
  13. Familiarity with requirements and changes management systems (i.e. Rational Doors and Change)
  14. Proficient use with Microsoft Office products Word, Excel, and Power Point
  15. Excellent written and verbal communication skills.


Nearest Major Market: Cincinnati