System Engineer H/F

Acusurgical is a fast‑growing start‑up in surgical robotics with a mission to help surgeons better treat patients and improve the lives of a large number of people affected by debilitating eye disease. We are looking for a highly motivated person, who shares our values.

Your Role

We are seeking a talented engineer to join our R&D team and contribute in the design and development of robotic surgical devices, to deliver robotic solutions that enhance patient care. This is an exciting opportunity to make a significant impact in a startup environment where your work will directly shape our product and company direction.

Key Missions

• Contribute to defining user needs and product system requirements for devices under development and products already on the market
• Analyze the various technical options available, present them to the team, and participate in selecting the best solution
• Participate in device risk management activities (patient risks, cybersecurity)
• Ensure that system requirements are translated into subsystem requirements, in collaboration with the 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)
• Participate in activities related to the clinical evaluation of products
• Contribute to the creation, updating, and management of technical documents
• Ensure compliance of deliverables
• Participate in impact analyses in the event of design changes to a device already on the market
• Support the certification team during evaluation tests and in preparing the required documentation
• Support the QARA (Quality and Regulatory) team in preparing regulatory documentation (CE, FDA, etc.)
• Support the Post Market Surveillance team in investigations and problem solving
• Contribute to improving work methods

Your Profile

• Engineering degree or Master’s degree in engineering or equivalent
• 5 years minimal in Medical Device industry, in system design activities or hardware/software development
• Strong analytical and problem‑solving skills, experience in writing specifications
• Knowledge of medical device environment standards IEC62304, ISO13485, ISO14971, ISO62366, ISO60601-1 etc. and regulations for CE and FDA
• Strong understanding of product development lifecycle, operating room requirements, risk management, usability, issues seen on the field
• Ability to use system engineering to break down complex problems into separate, solvable elements
• Excellent spoken and written English

Personal Qualities

• Pragmatic, customer‑oriented approach
• Strong problem‑solving skills and attention to detail
• Ability to work independently and take ownership of projects
• Excellent communication skills and ability to work in a collaborative team environment
• Adaptability and willingness to learn new technologies quickly
• Interest in medical technology and improving patient care
• Comfort working in a fast‑paced startup environment

We Offer

• Competitive salary and benefits package
• Opportunity to shape the future of robotic surgery
• Dynamic startup environment with potential for rapid growth
• Collaborative team culture in the beautiful city of Montpellier
• Sustainable mobility package
• A caring team that organizes wellness and sports activities