Principal R&D Systems Engineer

Johnson & Johnson Innovative Medicine•Boston, MA

3d•$117,000 - $201,250•Onsite

About The Position

The Principal Robotics Systems Engineer is a highly experienced individual contributor and technical specialist who leads systems engineering for a complex surgical robotic platform throughout its product lifecycle. The role ensures cohesive system behavior across hardware, software, controls, and clinical workflows in a safety-critical medical-device environment. It translates clinical user needs, surgeon workflows, and business objectives into traceable system and subsystem requirements and solutions. The position leads requirements flow-down, system architecture, risk management, verification strategies, and design reviews. It also supports regulatory submissions, product releases, design transfer, product launch, and post-market activities, ensuring compliance with applicable FDA regulations, ISO standards, IEC standards, and quality-system requirements. Working across engineering, clinical, quality, manufacturing, regulatory, and other teams, the role resolves technical trade-offs and leads system-level decisions without direct people-management responsibility.

Requirements

Bachelor’s or master’s degree in Systems Engineering, Software Engineering, Mechatronics, Electrical Engineering, or a related field.
8 or more years of experience in multidisciplinary systems engineering.
5 or more years of experience in surgical robotic systems or complex multidisciplinary medical devices.
Strong understanding of systems engineering principles and product development lifecycles, such as V-model, waterfall, and Agile.
Knowledge of embedded systems, firmware/software testing, and electromechanical systems.
Experience with requirements management tools such as DOORS, Jama, or Polarion.
Familiarity with test automation tools and scripting languages such as Python, LabVIEW, or MATLAB.
Excellent technical writing and communication skills.
Proficiency in sample-size calculation and statistical methods for data analysis.

Nice To Haves

Experience with Class II or Class III medical devices.
Certification in CQE, CQA, or Six Sigma.
Preferred skills include computer programming, cost-benefit analysis, critical thinking, data science, industry analysis, innovation, manufacturing technologies, organizing, problem solving, process improvements, prototyping, quality assurance, quality control, research and development, robotic automation, SAP Product Lifecycle Management, and technical credibility.
Additional listed skills include coaching, project management, report writing, requirements analysis, researching, scripting languages, software acquisitions, software development management, software engineering practices, software quality assurance, systems development lifecycle, technological savvy, and training people.

Responsibilities

Lead systems engineering for a surgical robotic platform, including system architecture, functional decomposition, and testable system and subsystem requirements.
Own requirements lifecycle and traceability from clinical user needs, surgeon workflows, and business objectives through system and subsystem requirements to verification and validation.
Coordinate cross-functional work across hardware, software, controls, mechanical, clinical, and verification and validation teams.
Lead integration of electromechanical hardware, embedded and application software, control algorithms, sensing, actuation, and user interaction.
Lead system-level risk management under ISO 14971, including hazard analysis, risk controls, verification of controls, and residual-risk assessment.
Own software-related system requirements, system behaviors, operational concepts, user stories, and clinical and technical use cases.
Ensure design-control activities comply with internal procedures and applicable regulatory requirements throughout the product lifecycle.
Lead system-level design and architecture reviews, resolve technical trade-offs, and support regulatory submission and product-release readiness.
Define, control, and maintain system interfaces and interface specifications across hardware, software, and mechanical domains.
Drive design-for-reliability practices, including robust design methodologies and Design of Experiments.
Partner with Human Factors and Clinical Engineering to meet usability requirements and mitigate use-related risks.
Lead standards and regulatory compliance activities, including requirements flow-down and alignment with applicable FDA, ISO, and IEC standards.
Collaborate with reliability and test engineering to meet reliability, durability, and service-life requirements, including support for accelerated life testing and reliability analysis.
Support design transfer and product launch, including manufacturing readiness, service considerations, and post-market surveillance, complaints, field issues, and failure analysis.
Apply Model-Based Systems Engineering and UML methods to define and manage system architecture, requirements, interfaces, and behavior.
Lead investigation of nonconformances, deviations, and test failures; perform root-cause analysis and drive corrective and preventive actions to closure.
Support audits, inspections, and regulatory submissions in coordination with regulatory affairs, quality, manufacturing, and clinical teams.
Communicate system-level risks, constraints, and opportunities to senior management, translating technical and clinical insights into business impacts and recommendations.
Identify critical paths and development risks and facilitate structured problem-solving across R&D teams.
Contribute to project planning, including resource and schedule planning.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility for the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and date of hire.
Sick time: 40 hours per calendar year; 48 hours for Colorado residents and 56 hours for Washington residents, subject to policy and date of hire.
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 a child’s birth, adoption, or foster-care placement.
Bereavement leave: 240 hours for an immediate family member and 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.