System Engineer H/F

Montpellier (France) WHEN: ASAP CONTRACT TYPE: Permanent Contract (CDI) * EDUCATION: MS or PhD in Engineering or equivalent. * EXPERIENCES: 5+ years of experience experience in an industrial environment with broad exposure to hardware / software / system design. * DESIRED EXPERIENCES: An experience in an industrial environment requiring knowledge of applicable regulations and standards (ISO, IEC, FDA). JOB SUMMARY SYSTEM ENGINEER H/F COMPANY DESCRIPTION Co-founded in 2017 by Bertin Nahum, Quantum Surgical is an innovative surgical robotic company which develops a unique mini-invasive surgery solution dedicated to liver cancer treatment by percutaneous ablation. Our platform combines robotics, image analytics, and artificial intelligence to enable physicians to better plan, treat, and evaluate their interventions. This pathology is the second deadliest cancer and affects 840 000 persons each year in the world. JOB DESCRIPTION We are looking for a SYSTEM ENGINEER M/F to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies. The System Engineer is involved for the design and development of new product technologies or features to fulfill unmet user needs. He/she will bring his/her expertise to ensure the delivery of a high quality, reliable, manufacturable, serviceable, and compliant product. The candidate should have demonstrated experience in a system engineering or equivalent role for the design of complex systems within a regulated environment. He/she will focus on innovation, performance, and safety. He/she will interface with engineers (Software, Robotics, Mechanical, Electrical, Test), Quality/Regulatory as well as Project Management, Marketing and Clinical teams. Your missions will be the following: * Work cross-functionally and participate to the design & development of product features * Interact closely with the Lead System Designer to perform adequate system engineering activities all along project activities * Interact with marketing & clinical teams to define product technical requirements * Participate in the risk management and usability engineering activities * Participate to design reviews and reduction of main technical risks together with Subject Matter Experts * Participate in conflicting requirements resolution and requirements traceability * Review software and hardware product specifications to ensure effective flow down from system requirements * Participate to the product architecture specification balancing implementation complexity, risks, manufacturability, serviceability and quality * Participate to the development of test methodologies and test systems to ensure product performance over all intended use and stress conditions. * Participate to the production of Instruction For Use related to the company’s products * Support the Test Engineers for verification activities * Participate to the validation activities and production of related deliverables * Support the design transfer & manufacturing teams to establish the device DMR * Support the RA team to establish the regulatory filings (CE, 510k, etc.) * Support the QA Team to handle design changes, product complaints, non-conformance, CAPA, post market surveillance, audit findings. PROFILE * You have an MS in Engineering or equivalent. * You have an experience in an industrial environment with broad exposure to hardware / software / system design. * You have a technical expertise in one or more engineering disciplines. * You have an experience writing requirements and design specifications. * You are pragmatic, customer focus approach. * You have solid analytical and problem-solving skills. * You are self-motivated, curious and open-minded. * You have excellent communication and documentation skills. * You are able to work across functions and team boundaries. * You are highly proficient in oral and written English. * Ideally, you an experience in an industral environment requiring knowledge of applicable regulations and standards (ISO, IEC, FDA). * Ideally, you are familiar with design controls in an FDA regulated environment. * Ideally, you have experience with Agile development methodology. WORKING AT QUANTUM SURGICAL MEANS * Joining a talented, dynamic, and multicultural team whilst being part of the technological and human adventure of a company in full evolution. * Sharing our culture of innovation, team spirit and result-oriented * Taking up technical challenges * Benefiting from a competitive compensation (fixed salary + variable, BSPCE)