Job description

Job brief

We are looking for a Test and Field Engineer who will develop verification and validation plans, write and execute tests for development & manufacturing for our medical device products. In addition, this position covers installation and qualification at customer site as well conducting research at customer sites to resolves problems quickly.

In this position at ARTIDIS you will work closely with development and the production team to ensure that all requirements are properly covered with tests and also to continuously improve the test strategy and efficiency of testing while the production is scaled up and development and production processes develop. Ultimately, you’ll ensure our final products meet our safety and quality standards and the running of ARTIDIS devices at customer sites. Further, you will contribute to development and production how to improve designs and processes.

Duties & Responsibilities

  • Meeting with the development team to determine product testing parameters.
  • Writing test plans and creating test cases for the product including development of test systems
  • Conducting quality assurance and designing performance tests using the new testing procedures.
  • Troubleshooting any errors and streamlining the testing procedures.
  • Writing up the final QA and test procedures
  • Analyze test results, detect issues and track root causes
  • Ensuring all tests and procedures meet company and industry standards (ISO1385, In-vitro diagnostic devices).
  • Preparing test and improvements reports for development and production.
  • Design and execution of tests to prove the analytical validity of the ARTIDIS products
  • Install new systems and technology in the US and Europe
  • Execute repairs and technical improvements
  • Ensure proper maintenance of onsite equipment
  • Diagnose construction or machinery problems

Qualifications

  • Engineering Background
  • Previous work experience as a test engineer for development and production of medical devices
  • Previous work experience as a field engineer installing and maintaining diagnostic or medical devices at customer site
  • Familiarity with testing tools
  • Knowledge of diagramming software including Gliffy, Microsoft Viso, and AutoCAD
  • Extensive knowledge of engineering and testing procedures.
  • Good problem-solving skills and attention to detail
  • Ability to project manage
  • Ability to troubleshoot and think out of the box
  • High-level technical writing skills
  • Hands-on experience with Quality Management Systems (QMS)
    Knowledge of quality standards and regulations for medical devices
  • Oustanding communication skills
  • Ability to work internationally and occasionally weekends

Working conditions

The environment is a typical start-up with an intrinsically motivated international team. Our office is a great place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team and a work serving a highly meaningful purpose. This position also comes with potential frequent traveling for the execution of experiments, on-site customer support or trouble shooting. The job position comes with a competitive salary, a bonus, and an ESOP plan for outstanding performance.

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