Director R&D Nav Software

Johnson & Johnson • Boston, MA

1d • Hybrid

About The Position

The Director R&D Software Navigation will lead a growing software team responsible for delivering next generation surgical navigation systems. This role is a critical technical and people leadership position within Navigation Systems R&D for 5 platforms, combining deep expertise with strategic ownership of software architecture, execution, and quality. This role is accountable for leading a team of Software Engineers and is responsible for defining, building, and sustaining robust, scalable, and safety critical software platforms that meet clinical, user, and regulatory requirements. Working closely with systems, hardware, clinical, manufacturing, quality, and regulatory partners, this role ensures that software solutions are architected and executed to meet system level performance, safety, and reliability objectives. This position requires a functional & technical leader who can operate effectively in a highly regulated, multidisciplinary surgical environment, while mentoring teams, driving innovation, and enabling predictable, high quality delivery.

Requirements

• Bachelor’s or Master’s degree in Computer Science, Electrical Engineering, Computer Engineering, or a related technical discipline.
• 10+ years: Developing software from concept through commercial release (SaMD experience preferred)
• 7+ 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 (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 10 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)

Nice To Haves

• Performing annual individual performance reviews and developing S.M.A.R.T goals for software developers
• Translating user requirements from Medical professionals into actionable software development tasks
• Writing technical documentation in a regulated medical industry
• AI/ML model implementation in SAMD production systems
• Complex problem solving
• Global release and support of production systems used by external customers

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director