Sr Navigation Systems Software Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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About Orthopaedics

Fueled by innovation at the intersection of biology and technology were 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 thats 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 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 nextgeneration surgical navigation systems. This role is a critical technical and peopleleadership 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 safetycritical 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 systemlevel 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 highquality delivery.

Job Responsibilities:

. Lead the full lifecycle development of software subsystems for surgical navigation platforms from early concept and prototyping through verification release and postmarket support.

Collaborate with senior engineers and architects to define own and evolve the software platform and architecture ensuring scalability realtime performance safety cybersecurity and longterm 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 crossdisciplinary technical tradeoff 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 systemlevel testing to improve quality and delivery predictability.

Champion metricsdriven 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 nonconformances 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 postmarket surveillance and controlled software updates.

Build mentor and retain a highperforming 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 businessrelated 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:

Bachelors or Masters 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 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 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-PN2 #DePuySynthes

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Manager