Sr Robotics Systems Engineering Manager

Johnson & Johnson Innovative Medicine•Boston, MA

22h•$137,000 - $235,750•Hybrid

About The Position

The Senior Robotics Systems Engineering Manager leads a multidisciplinary team of systems engineers, providing technical and organizational leadership for a complex surgical robotic platform throughout its entire product lifecycle. This role is crucial for ensuring cohesive system behavior across hardware, software, controls, and clinical workflows, applying rigorous systems engineering principles to a safety-critical medical robotic system. The manager collaborates closely with commercial, clinical, and product management stakeholders to translate user needs and business objectives into well-defined system requirements and successful new product introductions. Key responsibilities include leading the end-to-end requirements flow-down process, from stakeholder engagement to system architecture definition and decomposition into testable subsystem requirements. The position drives alignment between system architecture and implementation to meet performance, safety, reliability, and usability goals. Furthermore, this role is vital for regulatory submissions and product releases, overseeing design control activities in compliance with FDA regulations, ISO 13485, IEC standards, and other applicable requirements, including system-level risk management, traceability, verification strategies, and design reviews. Continuous collaboration with electrical, software, controls, mechanical, clinical, quality, manufacturing, and V&V teams is essential for cross-functional integration, technical trade-off resolution, and system-level decision-making to deliver a cohesive, compliant, and high-performing robotic system.

Requirements

Bachelor’s or master’s degree in Systems Engineering, Mechatronics Electrical Engineering, or related field
7+ years of experience in multidisciplinary systems engineering
Knowledge of embedded systems, firmware/software testing, and electromechanical systems
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)
Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB)
Excellent technical writing and communication skills

Nice To Haves

Experience with Class II or Class III medical devices is preferred.
Certification in CQE, CQA, or Six Sigma is a plus.
Proficient in sample size calculation and statistical methods for analyzing data.
Developing Others
Inclusive Leadership
Innovation
Leadership
Operations Management
Process Improvements
Requirements Analysis
Research and Development
Researching
SAP Product Lifecycle Management
Scripting Languages
Software Acquisitions
Software Development Management
Software Engineering Practices
Software Quality Assurance (SQA)
Stakeholder Engagement
Systems Development Lifecycle (SDLC)
Tactical Planning
Team Management
Technologically Savvy
Vendor Management

Responsibilities

Lead and develop a multidisciplinary systems engineering team responsible for the definition of system architecture, decomposition of system functionality, and development of clear, testable system‑level and subsystem requirements for a complex surgical robotic platform.
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 through verification and validation.
Drive close collaboration across hardware, software, controls, mechanical, clinical, and V&V teams to ensure system requirements are technically sound, fully testable, and aligned with real‑world clinical use cases and robotic performance needs.
Lead system architecture development for robotic systems, ensuring tight integration of electromechanical hardware, embedded and application software, control algorithms, sensing, actuation, and user interaction within a safety‑critical medical device environment.
Lead system‑level risk management activities in accordance with ISO 14971, including hazard analysis, risk control definition, risk verification, and residual risk assessment, with particular focus on robotic behaviors, software contributions to risk, and clinical use scenarios.
Own and lead software subsystem requirements, including definition of user stories, system behaviors, operational concepts, and detailed clinical and technical use cases that align software functionality with robotic system performance and user workflows.
Accountable for execution of all design control activities, ensuring compliance with internal procedures and external regulatory requirements throughout the product lifecycle, from concept through commercialization.
Chair and lead system‑level design reviews, architecture reviews, and risk mitigation reviews, driving cross‑functional alignment, resolving technical trade‑offs, and ensuring readiness for regulatory submission and product release.
Drive the integration of design‑for‑reliability practices, such as robust design and Design of Experiments (DoE), across system and subsystem development.
Partner with Human Factors (HF) Engineering and Clinical Engineering to ensure the system meets usability requirements and that all identified use‑related risks are effectively mitigated through appropriate risk control measures.
Lead standards and regulatory compliance efforts, owning the standards requirements flow‑down and ensuring 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 the robotic system meets defined reliability, durability, and service life requirements, 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 activities such as complaints investigation and field issue analysis.
Utilize Model‑Based Systems Engineering (MBSE) and UML practices to define, analyze, and manage system architecture, requirements, interfaces, and behavior.
Investigate and document nonconformances, deviations, and test failures, leading root cause analysis, defining corrective and preventive actions, and ensuring proper documentation and closure.
Interface with regulatory affairs, quality, manufacturing, and clinical teams to support internal and external audits, inspections, and regulatory submissions.
Communicate system‑level risks, roadblocks, and opportunities to senior management, translating technical and clinical insights into clear business impact and actionable recommendations.
Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
Support project resource and schedule planning.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year