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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

We are hiring for Senior Navigation Software Manager in a hybrid role to be based out of Boston, MA or Warsaw, IN

Purpose:

The Sr Navigation Software Manager 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, combining deep expertise with strategic ownership of software architecture, execution, and quality.

The Sr Navigation Software Manager 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‑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.

Qualifications:

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 (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)

Preferred:

·         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

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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