Director, Software Quality & Cybersecurity – MedTech Robotics

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 172,000 - 298,000; Full time

Benefits offered by this job

401(k) plan

Long-term incentive program

Pension plan

Job summary

Johnson & Johnson MedTech in Santa Clara, CA seeks a Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform. Lead global quality strategy, lifecycle, and cyber safeguards across AI/ML-enabled SaMD and MDDS with cross-functional partners.

The role focuses on FDA/ISO compliance, risk management, and design controls, ensuring inspection readiness and scalable governance across software products and development tools.

Qualifications

• Bachelor’s degree in engineering, Computer Science, Software Engineering, Biomedical engineering, or related field.
• Minimum 12 years in medical devices or regulated industry.
• Minimum 7 years in leadership of software quality or software engineering teams.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, FDA guidance.
• Hands-on with AI/ML-enabled device development and lifecycle management.
• Experience with cybersecurity governance and SPDF.
• On-site attendance at Santa Clara facility required 3 days/week.

Responsibilities

• Lead the Software Quality Engineering function for the OTTAVA robotic platform and digital technologies.
• Establish software quality strategies aligned with FDA/ISO standards and global regulations.
• Oversee software design controls, lifecycle processes, risk management, and cybersecurity controls.
• Ensure traceability between requirements, hazards, mitigations, validation, and cyber measures.
• Support regulatory submissions, inspections, and SPDF implementation.
• Develop and maintain compliant validation programs for software tools used in development and manufacturing.

Skills

Leadership

Software quality

Regulatory compliance

Cybersecurity governance

AI/ML in medical devices

Risk management

Cross-functional leadership

Education

Bachelor’s degree in engineering/CS/related field

Advanced degree preferred

Tools

SPDF

FDA QSR/QMSR

IEC 62304/ISO 13485/ISO 14971

Job description

Johnson & Johnson MedTech in Santa Clara, CA seeks a Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform. Lead global quality strategy, lifecycle, and cyber safeguards across AI/ML-enabled SaMD and MDDS with cross-functional partners.

The role focuses on FDA/ISO compliance, risk management, and design controls, ensuring inspection readiness and scalable governance across software products and development tools.