Principal Robotics System Engineer

Johnson & Johnson seeks a Principal Robotics System Engineer in Allschwil, CH, to lead systems engineering for a surgical robotic platform across its lifecycle.

This position serves as a senior technical specialist without direct people management duties. The individual will guide all systems engineering activities for a complex surgical robotic device, partnering with clinical, commercial, and product teams to convert user needs and business goals into precise system requirements and successful product launches.

Responsibilities

• Direct the full systems engineering process for a surgical robotic platform, covering architecture definition, functional decomposition, and the creation of verifiable system and subsystem requirements.
• Manage the complete requirements lifecycle, ensuring traceability from clinical needs and surgeon workflows through to hardware, software, and verification activities.
• Foster collaboration across hardware, software, controls, mechanical, and clinical teams to guarantee that system requirements are technically robust and aligned with real-world clinical scenarios.
• Oversee system architecture development, integrating electromechanical components, embedded software, control algorithms, and user interfaces within a safety-critical context.
• Conduct system-level risk management per ISO 14971, including hazard analysis, risk control definition, verification, and residual risk assessment.
• Define software-related system requirements, including operational concepts, user stories, and detailed clinical and technical use cases.
• Ensure adherence to design control procedures and external regulatory standards throughout the product lifecycle.
• Lead system-level design and architecture reviews, resolving technical trade-offs and ensuring readiness for regulatory submission and product release.
• Define and maintain system interfaces and specifications to ensure compatibility across hardware, software, and mechanical domains.
• Implement design for reliability practices, including robust design methodologies and Design of Experiments (DoE).
• Collaborate with Human Factors and Clinical Engineering to meet usability requirements and mitigate use-related risks.
• Drive compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, IEC 62304, ISO 14971, and other relevant standards.
• Work with reliability and test engineering teams to achieve defined reliability, durability, and service life targets.
• Support design transfer and product launch activities, including manufacturing readiness and post-market surveillance.
• Apply Model-Based Systems Engineering (MBSE) and UML methods to manage system architecture, requirements, interfaces, and behavior.
• Investigate nonconformances, deviations, and test failures, performing root cause analysis and driving corrective and preventive actions (CAPA).
• Interface with regulatory affairs, quality, manufacturing, and clinical teams to support audits, inspections, and regulatory submissions.
• Communicate system-level risks, constraints, and opportunities to senior management, translating technical insights into business impact.
• Identify critical paths and address development risks, facilitating structured problem-solving across R&D teams.
• Support project planning activities, including input to resource and schedule planning.

Requirements

• Bachelor’s or master’s degree in Systems Engineering, Software Engineering, Mechatronics, Electrical Engineering, or a related field.
• 7+ years of experience in multidisciplinary systems engineering.
• 5+ years of experience in surgical robotic systems or complex multidisciplinary medical devices.
• Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).
• Experience with requirements management tools (e.g., DOORS, Jama, Polarion).
• Excellent technical writing and communication skills.
• Proficient in sample size calculation and statistical methods for analyzing data.

Nice to have

• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, and electromechanical systems.
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).
• Certification in CQE, CQA, or Six Sigma is a plus.

About the company

Johnson & Johnson is responsible to its employees who work with them throughout the world. The company provides an inclusive work environment where each person is considered as an individual. They respect the diversity and dignity of their employees and recognize their merit.

• Johnson & Johnson is responsible to its employees who work with them throughout the world.
• The company provides an inclusive work environment where each person is considered as an individual.
• They respect the diversity and dignity of their employees and recognize their merit.