Senior Navigation Systems Software Manager

Role Overview

• 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, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.

Requirements

• 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 .NET/C#, Python, Java, Front-End technologies (WPF, JS/TS, React, etc.), Scripting (Powershell, Batch)
• Significant experience leading concurrent project teams of multiple software engineers using Agile-Scrum methodology.
• Proven experience managing and directing the day-to-day work of more than 5 SW developers
• Proven experience as the Lead decision maker of software design based on end-to-end knowledge impacts
• Strong understanding of software and systems engineering principles
• Proven experience authoring technical documentation (preferably in a highly regulated environment)

Tech Stack

• Cyber Security
• Java
• JavaScript
• Python
• React
• TypeScript
• WPF
• .NET

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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year