Editor's note: While Eindhoven Medical Robotics is not an alumnus of HighTechXL, we wanted to share their job opening with the Brainport tech community.
Eindhoven Medical Robotics aims to be a world leader in surgical robotics. We work in close collaboration with hospitals, engineering partners, suppliers and universities worldwide. The surgeons supporting us are highly respected in their fields and enjoy solving the engineering challenges in surgery with us.
Your responsibilities will include:
. Ensure that our systems are safe for human use.
. Plan, design, develop, and execute test protocols that provide evidence of the quality and safety of the robotic surgical systems.
. Identify coverage of risks, requirements, architectural components, functions and performance; identify appropriate regression tests; assess risk and organize the test plan around risk priorities; analyze results, state conclusions, and assess residual risk after tests are complete; assess adequacy of support for conclusions by the test results.
. Analyze test data, identify non-conformance trends, generate concise engineering and executive summaries, and recommend design improvements.
. Document issues, using an issue tracking system, and report issues to engineering and clinical teams, monitor issues and resolution efforts and track to closure.
. Designing a test regimen to gather data proportionately to the need to reduce uncertainty and to provide evidence of risk mitigation; providing verification and validation results for incorporation into a risk management file and into a regulatory submission.
. Troubleshooting, systematically and effectively break down a system or process into subparts to identify failure mechanisms.
Education and Experience
. Education in an engineering discipline such as Biomedical, Mechanical, Electrical, Software Engineering or Computer Science is preferred.
. Experience in medical device development, verification and validation testing, and an understanding of the requirements for regulatory approval.
. Familiarity with regulations, standards, and guidance on risk management, usability, and design control for medical devices.
. Familiarity with SW programming in C, C++, scripting languages such as Python for generation of automated tests.
. Experience with automated testing tools (using and/or developing).
. Highly motivated team player with excellent social, coordination and communication skills.
. Ability to work in an international multicultural setting.
An attractive market conform remuneration package with excellent benefits will be offered.
Interested? Contact firstname.lastname@example.org