Sr Navigation Systems Software Manager

Senior Navigation Software Manager – Boston, MA / Warsaw, IN

The Senior Navigation Software Manager leads a growing software team responsible for delivering next‑generation surgical navigation systems. This critical technical and people‑leadership position combines deep expertise in software architecture and safe software design with strategic ownership of product strategy and execution.

• Lead the full lifecycle development of software subsystems for surgical navigation platforms, from early concept and prototyping through verification, release, and post‑market support.
• Collaborate with senior engineers and architects to define, own, and evolve the 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.
• Support controlled release pipelines aligned with design controls and change management.
• 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.
• 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 full‑stack software team.
• Support resource planning, staffing, and schedule estimation.
• Foster a culture of technical excellence, accountability, ownership, and continuous improvement.
• Identify and 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.
• Ensure that 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 assigned as needed.
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.

Required

• Bachelor’s or Master’s degree in Computer Science, Electrical Engineering, Computer Engineering, or a related technical discipline.
• 7+ years developing software from concept through commercial release (SaMD experience preferred).
• 5+ years directly managing a software team of more than 10 developers while acting as the main functional manager & technical point of contact.
• Significant, demonstratable hands‑on experience in more than one of the following technologies: .NET/C#, Python, Java, Front‑End technologies (WPF, JS/TS, React, etc.), Scripting…