Sr Robotics Systems Engineering Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

R&D Software/Systems Engineering

Job Category:

People Leader

All Job Posting Locations:

Boston Massachusetts United States of America Raynham Massachusetts United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at are hiring for Senior Robotics System Engineer in a hybrid role to be based out of Raynham or Boston MA

Job Overview:

The Senior Robotics Systems Engineering Manager leads a team of multidisciplinary systems engineers and provides technical and organizational leadership for a complex surgical robotic platform across its full product lifecycle. This role is responsible for ensuring cohesive system behavior across hardware software controls and clinical workflows applying rigorous systems engineering principles to a safetycritical medical robotic system.

This position partners closely with commercial clinical and product management stakeholders to translate clinical user needs surgeon workflows and business objectives into well-defined system requirements and successful new product introductions. The role ensures that customer clinical and regulatory expectations are effectively decomposed into robust traceable system and subsystem solutions.

The role leads the endtoend requirements flow-down process starting with identification and engagement of clinical and business stakeholders definition of user and system requirements development of system architecture and decomposition into clear testable subsystem requirements. The position drives alignment between system architecture decisions and downstream implementation to ensure performance safety reliability and usability objectives are met.

The Senior Robotics Systems Engineering Manager plays a critical role in regulatory submissions and product releases by leading the planning execution and documentation of design control activities in compliance with FDA regulations ISO 13485 IEC standards and other applicable regulatory and quality system requirements. This includes ownership of system-level risk management requirements traceability verification strategies and design reviews.

This role requires close and continuous collaboration with electrical engineering software controls mechanical engineering clinical quality manufacturing and verification & validation (V&V) teams. The Senior Robotics Systems Engineering Manager ensures crossfunctional integration resolves technical trade-offs and drives system-level decision-making across disciplines to deliver a cohesive compliant and highperforming robotic system.

Job Responsibilities:

In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

Lead and develop a multidisciplinary systems engineering team responsible for the definition of system architecture decomposition of system functionality and development of clear testable systemlevel and subsystem requirements for a complex surgical robotic platform.

Own the endtoend requirements lifecycle ensuring seamless flowdown 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 realworld 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 safetycritical medical device environment.

Lead systemlevel 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 systemlevel design reviews architecture reviews and risk mitigation reviews driving crossfunctional alignment resolving technical tradeoffs and ensuring readiness for regulatory submission and product release.

Drive the integration of designforreliability 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 userelated risks are effectively mitigated through appropriate risk control measures.

Lead standards and regulatory compliance efforts owning the standards requirements flowdown 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 systemlevel reliability analysis.

Support design transfer and product launch activities including manufacturing readiness service considerations and postmarket surveillance activities such as complaints investigation and field issue analysis.

Utilize ModelBased 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 systemlevel 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.

Qualifications/Requirements:

. Bachelors or masters degree in systems engineering Mechatronics Electrical Engineering or related field

7 years of experience in multidisciplinary systems engineering.

Experience with Class II or Class III medical devices is preferred.

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.

Certification in CQE CQA or Six Sigma is a plus.

Proficient in sample size calculation and statistical methods for analyzing data.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against based on disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit

#LI-PN2

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$137000.00 - $235750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys long-term incentive program.



Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Manager