We are looking for a system engineer specialized in instrumentation to join our Robotics & Integration team. You’ll refer directly to the Systems Lead.

As a system engineer in instrumentation, you will:

• Contribute to the definition of user needs and product system requirements for all clinical instrumentation associated to Ganymed’s product
• Participate in risk management activities of the devices
• Write and review instrumentation requirements, enforcing good practices and consistency with system requirements
• Manage the instrumentation verification strategy, planification, execution and reporting
• Participate to the technical documentation redaction and review
• Participate to the activities related to usability (strategy, protocols, execution, reports)
• Participate to the activities related to clinical evaluation
• Analyse the different functional and technical solutions and participate to the selection of the best option
• Ensure the conformity of the deliverables
• Participate to the impact analysis in case of a design change on a device already on the field
• Support the certification team for evaluation or certification tests and for the required files
• Support Quality and Regulatory teams for the regulatory files (CE, FDA, etc…)

Who we are looking for:

• Engineer diploma or equivalent university training
• Minimum 4 to 5 years of experience in medical device industry, preferably in robotic devices
• Knowledge of robotic aspects is a big plus: system, mechatronics, HW development
• Knowledge of the relevant regulatory environment
• Knowledge of the constraints related to the operating room.
• Proven experience in structuring and writing technical documentation
• Strong problem-solving, analysis and synthesis skills.
• Good communication skills and ability to work independently within a highly-motivated team environment.
• Fluent in English (Oral and written)