Director Software Quality Engineering & Cybersecurity

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:
Supply Chain Engineering

Job Sub Function:
Quality Engineering

Job Category:
People Leader

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

Johnson & Johnson MedTech's Robotics & Digital Surgery (RAD) business is seeking an accomplished Director Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform to be located at Santa Clara, CA.

The Director leads the quality engineering strategy and execution for software-enabled medical technologies across the OTTAVA robotic surgical platform.

This leader oversees software quality engineering activities supporting software in medical device including AI/ML components, Software as a Medical Device (SaMD), Medical Device Data Systems (MDDS), embedded software, connected digital systems, non-product software validation, and cybersecurity compliance.

This role partners closely with R&D, Regulatory Affairs, Medical Safety, Systems Engineering, Clinical, and enterprise cybersecurity teams to ensure software products and supporting systems meet global regulatory requirements, cybersecurity expectations, and company quality standards throughout the product lifecycle.

The Director establishes scalable quality systems, drive software development and validation excellence, supports regulatory submissions and inspections, and enable safe and compliant product commercialization.

Key Responsibilities:


* Lead the Software Quality Engineering function supporting the OTTAVA robotic surgical platform and associated digital technologies.


* Establish and execute software quality strategies aligned with FDA, ISO 13485, IEC 62304, ISO 14971, FDA cybersecurity guidance, and applicable global regulations.


* Provide oversight of software design controls, software lifecycle processes, software risk management, anomaly management, configuratio...