Navigation Systems Software Manager

Responsibilities

• Lead the full lifecycle development of embedded software subsystems for surgical navigation systems platforms, from early concept and prototyping through verification, release, and post‑market support.
• Define, own, and evolve the embedded software platform and architecture, ensuring scalability, real‑time performance, safety, cybersecurity, and long‑term maintainability.
• Establish technical direction and software roadmaps aligned with product strategy and system evolution.
• Ensure software designs are compliant with system requirements, user needs, intended use, 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 Dev Ops strategies appropriate for regulated embedded surgical robotics and navigation systems, including:
  • 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., IEC 62304) 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.

• Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
• Minimum of 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 Window based applications
• Strong experience with real‑time embedded systems, including RTOS‑based environments (e.g., QNX or similar real‑time operating systems).
• Strong understanding of software and 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.
• Experience with Class II or Class III medical devices is preferred.
• Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).