Director Software Quality Engineering & Cybersecurity (Medical Devices)

Location: Santa Clara, California, United States. Hybrid attendance is required, with at least 3 days per week on site at the Johnson & Johnson robotic campus.

Salary: $172,000–$297,850 base pay per year.

Company

Johnson & Johnson MedTech develops innovative, less invasive, and personalized healthcare and robotic surgery solutions.

What you will do

• Lead the Software Quality Engineering function for the OTTAVA robotic surgical platform and related digital technologies.
• Establish software quality strategies aligned with FDA, ISO 13485, IEC 62304, ISO 14971, FDA cybersecurity guidance, EU MDR, and other global regulations.
• Oversee design controls, software lifecycle processes, risk management, traceability, verification and validation, anomaly management, configuration management, and release readiness.
• Lead quality oversight for SaMD, MDDS, AI/ML-enabled devices, embedded software, connected systems, and non-product software validation.
• Direct cybersecurity governance, including secure product development, threat modeling, vulnerability management, penetration testing, SBOM governance, and post-market processes.
• Build and develop a high-performing Software QE organization through coaching, mentorship, metrics, continuous improvement, and cross-functional leadership.

Requirements

• Bachelor’s degree in engineering, Computer Science, Software Engineering, Biomedical Engineering, or a related technical field.
• At least 12 years of experience in medical devices, software-regulated environments, or other highly regulated industries.
• At least 7 years of leadership experience managing software quality or software engineering teams.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, FDA QSR/QMSR, FDA cybersecurity guidance, and global regulatory requirements.
• Hands-on experience with AI/ML-enabled device development, software lifecycle management, cybersecurity governance, SPDF, threat modeling, SBOM management, and vulnerability assessment.
• Experience with Agile development, DevOps methodologies, FDA submissions, inspections, regulatory audits, ISO certification audits, and MDSAP assessments.

Nice to have

• Advanced degree in a relevant technical field.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual merit.
• Participation in the company pension and 401(k) savings plans.
• Eligibility for the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, caregiver leave, bereavement leave, volunteer leave, and military spouse time off.