Principal R&D Systems Engineer

Johnson & Johnson Innovative Medicine•Boston, MA

3d•$120,000 - $207,000

About The Position

Johnson & Johnson is seeking a Principal Robotics Systems Engineer based in Boston, Massachusetts. This highly experienced individual contributor and technical specialist 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. The position translates clinical user needs, surgeon workflows, and business objectives into system requirements, architecture, and integrated subsystem solutions. It leads requirements flow-down and traceability, system-level risk management, verification strategies, design reviews, and design-control activities. The role partners with commercial, clinical, product management, engineering, quality, manufacturing, and regulatory teams to support compliant product development, regulatory submissions, product releases, design transfer, and post-market activities. It is a technical leadership role without direct people-management responsibility. The anticipated base pay range is $120,000–$207,000. Eligible employees may participate in the company’s retirement and savings plans, long-term incentive program, and time-off benefits, subject to applicable plan and policy terms. The job posting notes that Johnson & Johnson plans to separate its Orthopaedics business as DePuy Synthes; after the transaction, the employee is anticipated to work for DePuy Synthes under its employment processes, programs, policies, and benefit plans.

Requirements

Bachelor’s or master’s degree in Systems Engineering, Software Engineering, Mechatronics, Electrical Engineering, or a related field.
At least 8 years of experience in multidisciplinary systems engineering.
At least 5 years of experience in surgical robotic systems or complex multidisciplinary medical devices.
Knowledge of embedded systems, firmware and software testing, and electromechanical systems.
Strong understanding of systems engineering principles and product development lifecycles, such as V-model, waterfall, and Agile.
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.
Skills in 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.
Preferred skills listed include coaching, critical thinking, innovation, Model-Based Systems Engineering, organizing, project management, report writing, requirements analysis, research and development, researching, SAP Product Lifecycle Management, 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, functionality decomposition, and clear, testable system and subsystem requirements.
Own requirements lifecycle flow-down and traceability from clinical user needs, surgeon workflows, and business objectives through system and subsystem requirements to verification and validation.
Coordinate hardware, software, controls, mechanical, clinical, and verification and validation teams to align requirements with clinical use and robotic performance needs.
Lead system architecture and 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, and residual-risk assessment.
Own software-related system requirements, including system behaviors, operational concepts, user stories, and clinical and technical use cases.
Ensure design-control activities comply with internal procedures and external regulatory requirements throughout the product lifecycle.
Lead system-level design and architecture reviews, resolve technical trade-offs, and support readiness for regulatory submissions and product release.
Define, control, and maintain system interfaces and interface specifications across hardware, software, and mechanical domains.
Apply design-for-reliability methods, including robust design methodologies and Design of Experiments, during system and subsystem development.
Partner with Human Factors and Clinical Engineering to meet usability requirements and mitigate use-related risks.
Lead standards and regulatory compliance activities and requirements flow-down, including alignment with FDA 21 CFR Part 820, ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
Work with reliability and test engineering to meet reliability, durability, and service-life requirements, including accelerated life testing and system-level reliability analysis.
Support design transfer, manufacturing readiness, service considerations, product launch, and post-market surveillance, including complaints, field issues, and failure analysis.
Use Model-Based Systems Engineering and UML to define, analyze, and manage architecture, requirements, interfaces, and behavior.
Lead investigations of nonconformances, deviations, and test failures; conduct root-cause analysis and drive corrective and preventive actions to closure.
Work with regulatory affairs, quality, manufacturing, and clinical teams on audits, inspections, and regulatory submissions.
Communicate system-level risks, constraints, and opportunities to senior management and provide actionable recommendations tied to business impact.
Identify critical paths and development risks and facilitate structured problem-solving across R&D teams.
Provide input to project resource and schedule planning.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policy and date of hire.
Sick time: 40 hours per calendar year, with stated variations for Colorado and Washington residents.
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: up to 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.