Lead Product Security Architect

Johnson & Johnson Innovative Medicine • Santa Clara, CA

2d • Onsite

About The Position

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: Scientific/Technology All Job Posting Locations: Santa Clara, California, United States of America Job Description: About Surgery: 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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. 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 our Lead Product Security Architect position. This position will be located in Santa Clara, CA Purpose: The Lead Product Security Architect will own the cybersecurity architecture, system-level view, and technical implementation of the OTTAVA surgical robot, with potential to impact millions of patients and expand the capabilities of physicians globally. This role is not focused on enterprise IT, or cloud security operations. This individual will be a key technical and strategic leader on one of the most exciting programs in J&J and in healthcare in general! The candidate must bring a strong blend of security awareness, technical ability, and regulatory awareness. They must also balance depth in cybersecurity with a passionate focus on understanding and meeting the needs of clinicians and operating room staff. This role reports to the Sr. Director, Robotics Software.

Requirements

• 10+ years professional experience in software development or systems engineering with a focus on device security
• 5+ years experience with hands-on technical leadership in cybersecurity
• Demonstrated ability to deliver results on time within constraints by creatively adapting processes and using resources is required
• Experience with regulatory guidance (preferably FDA) on cybersecurity implementation and documentation, pre- and post-market surveillance, and risk-assessment is required
• Proficiency in software development for complex safety critical products, ideally within medical device or other highly regulated industries (i.e. defense, autonomous vehicles, aerospace, etc.)
• Demonstrated success in partnering and influencing across a matrix environment is required.
• Proven leadership designing system-level security architecture for embedded devices is required
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and partners is required
• Ability to travel up to 10%, international and domestic, is required

Nice To Haves

• Demonstrated hands-on experience with FDA Class II or III medical devices is VERY strongly preferred
• Experience with IEC 62304 is VERY strongly preferred.
• Previous experience with post-market vulnerability monitoring is preferred
• Experience reaching “across the aisle” to successfully partner with and problem solve alongside technical, support, and business partners in other parts of the company is preferred
• Experience with FDA audits and cloud certifications (e.g., SOC2) is preferred
• Understanding of robotic technology and general robotic surgery paradigms is preferred
• Experience with a global development team
• Previous experience successfully supporting or launching medical device products is preferred

Responsibilities

• Own the end-to-end cybersecurity architecture for the OTTAVA product, a FDA-regulated device, maintaining a system-level view of security and ensuring security-by-design from firmware and embedded software to external interfaces
• Be the singular R&D voice on security, clearly communicating and aligning approaches with internal (quality, information security, regulatory) and external (FDA) stakeholders
• Act as the technical authority for cybersecurity decisions and trade-offs
• Design and oversee implementation of technical cybersecurity controls, primarily based in software and network infrastructure
• Lead R&D cyber reviews and documentation (threat modeling, risk assessment) in partnership with internal collaborators
• Translate security risks into patient safety, regulatory, and business impact for non-security stakeholders
• Take a risk-based approach when assessing the relationship between cybersecurity needs, patient safety, regulatory expectations, and quality system requirements

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
• 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: Senior
• Education Level: No Education Listed