We are seeking a highly experienced Senior System Engineer / Architect to join our dynamic R&D team. The successful candidate will have a proven record of accomplishment in developing new medical devices and enhancing existing products. This role requires a deep understanding of system engineering principles, medical device standards, and regulatory requirements.

You will report directly to the System Lead.

You participate in the definition, design, development, documentation and testing of Ganymed Robotics products, working closely with R&D, QARA, Product teams and medical professionals. Within the R&D Team, you collaborate with mechanical engineers, electrical engineers, software and firmware engineers.

Key responsibilities:

• Collaborate with cross-functional teams including product, mechanical, electrical, software, quality, regulatory and clinical engineers to design and develop innovative solutions.

• Ensure compliance with relevant medical device standards and regulations throughout the product lifecycle.

• Drive system trade-off discussions within new product developments by having a full understanding of system architecture and interfaces.

• Contribute to the definition and update of user and system requirements, specifications, and design documentation, along with stakeholders.

• Ensures the breakdown of system requirements to subsystem requirements, along with the sub-system stakeholders.

• Maintain and update the system architecture to reflect the current and future state of the product, ensuring it supports scalability, reliability, and performance.

• Develop methods to quantify subsystem interactions and their effects on system performance. Define requirements for key system performance parameters as they relate to accuracy, repeatability, safety, performance, and calibration.

• Manage risk retirement plans and ensure that all identified risks are mitigated to acceptable levels.

• Drive or participate in design reviews, and technical assessments.

• Drive or participates to impact analysis activities in case of a design change

• Conduct risk management activities including FMEA and hazard analysis.

• Conduct usability activities (strategy, protocols, execution, reports)

• Conduct integration and verification activities (strategy, protocols, execution, reports)

• Conduct validation activities (strategy, protocols, execution, reports)

• Provide technical leadership and mentorship to junior engineers.

• Participates to the activities related to clinical evaluation

• Ensure support for Design transfer activities

• 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…)

• Contribute to the improvement of working methods

• Engineer diploma or equivalent university training

• 7+ years of experience in medical device industry, preferably in robotic devices and/or in complex electrical medical devices such as medical imaging equipment, or diagnostic devices.

• Proven experience in developing and commercializing medical devices (New Product development phase and post-market phase).

• Knowledge of the regulatory environment (ISO 13485, ISO 14971, FDA 21 CFR Part 820, IEC 62366, IEC 60601, IEC 62304, ISO 14971)

• Proven experience in developing methods to quantify subsystem interactions and their effects on system performance (accuracy or imaging).

• Knowledge of cybersecurity standards for medical devices

• Knowledge of the operating room environment and constraints.

• Ability to successfully establish and maintain strong working relationships with various stakeholders including R&D team members, Product Managers, Project Managers

• Excellent written and verbal communication skills

• Strong interpersonal, communications, presentation, and negotiation skills

• English proficiency

Skills and experience as a plus:

• IREB Certified Professional for Requirements Engineering (CPRE)

• Familiarity with Agile development methodologies

• Knowledge of robotic-specific aspects: system, algorithmic and functional, mechatronics, HW development, software development.

• Knowledge of Requirement Management tools