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, Warsaw, Indiana, United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we're 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 that's 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 https://www.jnj.com/medtech

We are hiring for Senior Navigation Systems Engineering Manager in a hybrid role to be based out of Raynham or Boston, MA

Purpose:

The Senior Navigation Systems Engineering Manager leads a team of multidisciplinary systems engineers and provides technical and organizational leadership for a complex surgical navigation 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 safety-critical medical navigation 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 end-to-end 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 Navigation 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 Navigation Systems Engineering Manager ensures cross-functional integration, resolves technical trade-offs, and drives system-level decision-making across disciplines to deliver a cohesive, compliant, and high-performing navigation system.

Job 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 navigation 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 navigation system performance needs.
• Lead system architecture development for surgical navigation 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 navigation system 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 navigation 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.
• Define, control, and maintain system and subsystem interfaces and interface specifications, ensuring compatibility and robust integration across hardware, software, and mechanical domains.
• 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 navigation 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.

Qualifications:

Required:
• Bachelor's or master's degree in systems engineering, Mechatronics Electrical Engineering, or related field.
• 7+ years of experience in multidisciplinary systems engineering.
• 5+ years of experience in surgical robotic systems, surgical navigation systems or complex multidisciplinary medical devices.
• 3+ Experience leading systems engineering teams.
• 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).
• Excellent technical writing and communication skills.

Preferred:
• Experience with Class II or Class III medical devices is preferred.
• Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).

. 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.

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 :
$137,000.00 - $235,750.00

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's 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: - https://www.careers.jnj.com/employee-benefits