Navigation Systems Software Manager

Job Summary Senior Navigation Systems Software Manager – a hybrid role based in Boston, MA or Warsaw, IN. Responsible for leading the embedded software team that delivers next‑generation surgical navigation systems, defining software architecture, ensuring quality, and mentoring high‑performing teams. Job Responsibilities Lead end‑to‑end development of embedded software subsystems for surgical navigation systems, from concept to post‑market support. Define, own, and evolve the embedded software platform and architecture, ensuring scalability, real‑time performance, safety, cybersecurity, and maintainability. Establish technical direction and software roadmaps aligned with product strategy and system evolution. Ensure software designs meet system requirements, user needs, hazard mitigations, and regulatory expectations. Partner with systems engineering, hardware, clinical, usability/human factors, quality, and manufacturing teams to translate user needs into clear, testable, traceable software requirements. Lead and participate in architecture reviews, design reviews, and cross‑disciplinary technical trade‑off discussions. Collaborate on the design and implementation of safe, intuitive user interfaces with human factors and clinical teams. Support regulatory submissions, audits, inspections, and DHF completeness in partnership with quality and regulatory affairs. Establish and own DevOps strategies appropriate for regulated embedded surgical robotics and navigation systems: Continuous Integration (CI) with automated builds, static analysis, and test execution. Controlled release pipelines aligned with design controls and change management. Source control, branching strategies, and configuration management for safety‑critical products. Lead adoption of automated unit‑testing, integration, and system‑level testing to improve quality and delivery predictability. Champion metrics‑driven development (build health, test coverage, defect trends) to drive continuous improvement. Lead software FMEA activities, define and verify effective risk mitigation strategies, and ensure software safety levels align with system requirements and applicable risk controls. Contribute to hazard analysis, risk management, and design controls in accordance with medical device regulations. Ensure compliance with applicable medical device software standards (e.g., IEC62304) and internal quality processes. Investigate non‑conformances, deviations, and test failures; drive root cause analysis (RCA) and corrective actions. Lead software planning and execution across development phases, including prototyping, design, verification, validation, and release. Support design transfer, manufacturing readiness, and product launch activities. Participate in complaint investigations, post‑market surveillance, and controlled software updates. Build, mentor, and retain a high‑performing embedded software team. Identify project critical paths, proactively manage risks, and facilitate cross‑functional problem solving. Support resource planning, staffing, and schedule estimation. Communicate risks, opportunities, and execution status clearly to senior leadership. Foster a culture of technical excellence, accountability, ownership, and continuous improvement. Communicate business‑related issues, risks, and opportunities to senior management in a timely and effective manner. Interface with regulatory, quality, and manufacturing teams to support audits and inspections. For those who supervise or manage a staff, ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all federal, state, local and Company regulations, policies, and procedures. Perform other duties as assigned. Qualifications Required: Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline. Minimum 7+ years of hands‑on experience developing embedded software for medical devices. Deep expertise in embedded C/C++ development, including low‑level drivers, middleware, and application‑level software. Expertise in Microsoft.NET development framework and Windows‑based applications. Strong experience with real‑time embedded systems, including RTOS‑based environments (e.g., QNX or similar). Strong understanding of software and systems engineering principles and product development lifecycle (V‑model, waterfall, Agile). Experience with requirements management tools (e.g., DOORS, Jama, Polarion). Excellent technical writing and communication skills. Preferred: Experience with ClassII or ClassIII medical devices. Familiarity with test automation tools and scripting languages (Python, LabVIEW, MATLAB). EEO Statement 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. 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. #J-18808-Ljbffr 6149-DePuy Synthes Products Inc. Legal Entity