Director R&D Nav Software

Johnson Johnson; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Boston seeks a Director of R&D Software Navigation to lead a growing software team delivering next-generation surgical navigation systems. You will define architecture, drive delivery, and ensure safety and regulatory compliance in a highly regulated environment.

Collaborate with systems, hardware, clinical, usability, quality, and regulatory partners to build scalable platforms, mentor engineers, and champion automated testing and quality metrics.

Responsibilities

• Lead full lifecycle development of software subsystems for surgical navigation platforms.
• Define software platform architecture with scalability and real-time performance.
• Coordinate with systems, hardware, clinical, usability, and quality teams.
• Ensure regulatory compliance and safety with IEC 62304 considerations.
• Mentor software engineers and drive high-quality delivery.
• Lead architecture and design reviews.
• Support regulatory submissions and DHF completeness.

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

R&D Software/Systems Engineering

Job Category:

People Leader

All Job Posting Locations:

Boston, Massachusetts, United States of America

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Director R&D Software Navigation to be based out of Boston, MA

Purpose:

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.

Job 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 conform