Sr Navigation Systems Engineering Manager

About the role

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.

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.

Requirements

• 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+ years of 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 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