Principal Robotics Systems Engineer, Surgical Automation

Johnson & Johnson MedTech; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson MedTech in Boston, MA is seeking a Principal Robotics Systems Engineer to lead system engineering for a complex surgical robotic platform across its lifecycle. You will ensure cohesive behavior across hardware, software, controls, and clinical workflows.

This role partners with clinical, commercial, and product management to translate user needs into robust requirements, drive design reviews, and support regulatory submissions under FDA/ISO standards.

Qualifications

• 8+ years of multidisciplinary systems engineering experience.
• 5+ years in surgical robotics or complex medical devices.
• Knowledge of embedded systems, firmware/software testing.
• Experience with requirements management tools (DOORS, Jama, Polarion).
• Excellent technical writing and communication skills.

Responsibilities

• Lead 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.
• Own 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.
• Drive 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.
• Lead 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.
• Lead 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.
• Own 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.
• Ensure execution of design control activities in compliance with internal procedures and external regulatory requirements across the full product lifecycle (concept through commercialization).
• Lead system‑level design and architecture reviews, driving cross‑functional alignment, resolving technical trade‑offs, and ensuring readiness for regulatory submission and product release.
• Define, control, and maintain system interfaces and interface specifications, ensuring compatibility and robust integration across hardware, software, and mechanical domains.
• Drive design for reliability practices, including robust design methodologies and Design of Experiments (DoE), across system and subsystem development.
• Partner with Human Factors and Clinical Engineering to ensure usability requirements are met and use‑related risks are effectively mitigated.
• Lead 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.
• Collaborate 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.
• Support design transfer and product launch activities, including manufacturing readiness, service considerations, and post‑market surveillance (complaints, field issues, and failure analysis).
• Apply Model‑Based Systems Engineering (MBSE) and UML methods to define, analyze, and manage system architecture, requirements, interfaces, and behavior.
• Lead investigation of nonconformances, deviations, and test failures, performing root cause analysis and driving corrective and preventive actions (CAPA) to closure.
• 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 and clinical insights into clear business impact and actionable recommendations.
• 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.

Skills

8+ years systems engineering

Embedded systems knowledge

Regulatory awareness

Technical writing

Cross-functional collaboration

Education

Bachelor’s or Master’s in a relevant field

Tools

DOORS

Jama

Polarion

Job description

Johnson & Johnson MedTech in Boston, MA is seeking a Principal Robotics Systems Engineer to lead system engineering for a complex surgical robotic platform across its lifecycle. You will ensure cohesive behavior across hardware, software, controls, and clinical workflows.

This role partners with clinical, commercial, and product management to translate user needs into robust requirements, drive design reviews, and support regulatory submissions under FDA/ISO standards.