The role
03We are searching for Principal Robotics Systems Engineer to be based out of Boston, MA or Grenoble, France or Zuchwil, Switzerland. Purpose: Principal Robotics Systems Engineer is a highly experienced individual contributor and technical specialist responsible for leading all aspects of systems engineering for a complex surgical robotic platform across its full product lifecycle. This role ensures cohesive system behavior across hardware, software, controls, and clinical workflows, applying rigorous systems engineering principles to a safety-critical medical device. This position partners closely with commercial, clinical, and product management stakeholders to translate clinical user needs, surgeon workflows, and business objectives into well-defined system requirements and successful new product introductions. The role ensures that customer, clinical, and regulatory expectations are effectively decomposed into robust, traceable system and subsystem solutions. The Principal Robotics Systems Engineer leads the end-to-end requirements flow-down process, including identification and engagement of clinical and business stakeholders, definition of user and system requirements, development of system architecture, and decomposition into clear, testable subsystem requirements. The role drives alignment between system architecture decisions and downstream implementation to ensure performance, safety, reliability, and usability objectives are achieved. This role plays a critical part in regulatory submissions and product releases by leading the planning, execution, and documentation of design control activities in compliance with FDA regulations, ISO 13485, IEC standards, and other applicable quality system requirements.
01Lead all aspects of systems engineering for a complex surgical robotic platform, including definition of system architecture, decomposition of system functionality, and development of clear, testable system and subsystem requirements.
02Own the end-to-end requirements lifecycle , ensuring seamless flow-down and traceability from clinical user needs, surgeon workflows, and business objectives through system, subsystem, hardware, and software requirements, and ultimately verification and validation.
03Drive cross-functional collaboration across hardware, software, controls, mechanical, clinical, and V&V teams to ensure system requirements are technically sound, testable, and aligned with real-world clinical use cases and robotic performance needs.
04Lead system architecture development , ensuring robust integration of electromechanical hardware, embedded and application software, control algorithms, sensing, actuation, and user interaction within a safety-critical environment.
05Lead system-level risk management activities in accordance with ISO 14971, including hazard analysis, risk control definition, verification of risk controls, and residual risk assessment, with emphasis on robotic behaviors, software contributions, and clinical use scenarios.
06Own software-related system requirements , including definition of system behaviors, operational concepts, user stories, and detailed clinical and technical use cases that align software functionality with system performance and user workflows.
07Ensure execution of design control activities in compliance with internal procedures and external regulatory requirements across the full product lifecycle (concept through commercialization).
08Lead system-level design and architecture reviews , driving cross-functional alignment, resolving technical trade-offs, and ensuring readiness for regulatory submission and product release.
09Define, control, and maintain system interfaces and interface specifications , ensuring compatibility and robust integration across hardware, software, and mechanical domains.
10Drive design for reliability practices , including robust design methodologies and Design of Experiments (DoE), across system and subsystem development.
11Partner with Human Factors and Clinical Engineering to ensure usability requirements are met and use-related risks are effectively mitigated.
12Lead standards and regulatory compliance activities , including requirements flow-down and alignment with FDA 21 CFR Part 820, ISO 13485, IEC 60601, IEC 62304, ISO 14971, and other applicable standards.
13Collaborate with reliability and test engineering teams to ensure defined reliability, durability, and service life requirements are achieved, including support for accelerated life testing and system-level reliability analysis.
14Support design transfer and product launch activities , including manufacturing readiness, service considerations, and post-market surveillance (complaints, field issues, and failure analysis).
15Apply Model-Based Systems Engineering (MBSE) and UML methods to define, analyze, and manage system architecture, requirements, interfaces, and behavior.
16Lead investigation of nonconformances, deviations, and test failures , performing root cause analysis and driving corrective and preventive actions (CAPA) to closure.
17Interface with regulatory affairs, quality, manufacturing, and clinical teams to support audits, inspections, and regulatory.
