Director, Software Quality & Cybersecurity

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

Job summary

Johnson & Johnson MedTech seeks an accomplished Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform in Santa Clara, CA. The role leads QE strategy across SaMD, MDDS, embedded software, and cybersecurity life cycle, partnering with R&D, Regulatory, and security teams to ensure regulatory compliance and product safety.

The director will drive scalable quality systems, software validation, and CAPA programs, while preparing for FDA inspections and global audits.

Qualifications

• Bachelor’s degree in engineering, CS, or related field; advanced degree preferred.
• Minimum 12 years in medical devices or highly regulated industries.
• Minimum 7 years leadership in software quality or engineering.

Responsibilities

• Lead Software Quality Engineering for OTTAVA platform and digital tech.
• Ensure software quality strategies meet FDA ISO13485 IEC62304 and cybersecurity guidance.
• Oversee software design controls, lifecycle processes, risk management, and validation.
• Collaborate with Regulatory Affairs for submissions and cybersecurity deliverables.
• Maintain traceability from requirements to verifications and cybersecurity controls.
• Lead cyber risk management, SBOM, threat modeling, and vulnerability assessment.

Skills

Cybersecurity

Design Controls

Leadership

Risk Management

FDA Submissions

Coaching

Change Management

Education

Bachelor’s degree in engineering or related field

Advanced degree preferred

Job description

Johnson & Johnson MedTech seeks an accomplished Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform in Santa Clara, CA. The role leads QE strategy across SaMD, MDDS, embedded software, and cybersecurity life cycle, partnering with R&D, Regulatory, and security teams to ensure regulatory compliance and product safety.

The director will drive scalable quality systems, software validation, and CAPA programs, while preparing for FDA inspections and global audits.