System Engineer H/F

Acusurgical is a high-growth MedTech startup specializing in surgical robotics, based in Montpellier. Our mission is to revolutionize medical care by developing advanced technologies to assist surgeons and improve the lives of patients with disabling diseases. Combining technical expertise and human impact, we offer a dynamic and collaborative environment where every talent contributes to shaping the future of medicine.

As a System Engineer, you will be at the heart of our R&D team, contributing to the design and development of surgical robotic devices. You will work closely with mechanical, software, quality, and production engineers to ensure safe, high-performance, and compliant solutions.

Key Responsibilities

- Define user needs and system requirements for devices under development and already on the market.
- Analyze technical options, present them to the team, and help choose the best solution.
- Participate in risk management activities related to devices (patient risks, cybersecurity).
- Ensure that system requirements are translated into subsystem requirements, in collaboration with subsystem teams.
- Participate in integration and verification activities (strategy, protocols, execution, reports).
- Participate in validation activities (strategy, protocols, execution, reports).
- Participate in usability activities (strategy, protocols, execution, reports).
- Support design transfer activities with technical expertise.
- Contribute to the creation, updating, and management of technical documentation.
- Ensure compliance of deliverables.
- Participate in impact analyses in case of design changes to a marketed device.
- Support the certification team during evaluation tests and in preparing required documentation.
- Assist the QA/RA team in preparing regulatory documentation (CE, FDA, etc.).
- Support the post-market surveillance team in investigations and problem resolution.