Director, Software Quality & Cybersecurity - Robotics Platform

Biopharma Careers; Santa Clara (CA); On-site; USD 172,000 - 298,000; Full time

Benefits offered by this job

Pension plan

401(k)

Long-term incentive program

Vacation and paid time off

Job summary

Johnson & Johnson MedTech is seeking a Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform in Santa Clara, CA. The role leads software QE and cybersecurity programs for SaMD/MDDS across the lifecycle, partnering with R&D, Regulatory, and enterprise security teams.

The ideal candidate has 12+ years in regulated medical devices, 7+ years in leadership, and deep knowledge of FDA/ISO frameworks, with hands-on AI/ML experience and strong risk management

Qualifications

• Bachelor’s degree in engineering, CS, SWE, biomedical engineering, or related field.
• Minimum 12 years in medical devices or regulated industries.
• Minimum 7 years leadership in software quality or software engineering.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, FDA QSR/QMSR, and FDA cybersecurity guidance.
• Hands-on AI/ML-enabled device development and SDLC.
• SPDF, threat modeling, SBOM management, vulnerability assessment.
• On-site attendance at Johnson & Johnson MedTech Santa Clara facility for at least 3 days a week.

Responsibilities

• Lead Software Quality Engineering for OTTAVA robotic platform and digital technologies.
• Establish software quality strategies aligned with FDA, ISO 13485, IEC 62304, ISO 14971, FDA cybersecurity guidance, and global regs.
• Oversee software design controls, lifecycle processes, risk management, anomaly management, configuration management, and release readiness.
• Ensure robust traceability between software requirements, hazards, verifications, validations, and cybersecurity controls.
• Lead quality and compliance activities for SaMD and MDDS.
• Partner with Regulatory Affairs for regulatory submissions, FDA interactions, and cybersecurity deliverables.
• Maintain SPDF governance and audit-readiness.

Skills

Software QE

Cybersecurity governance

Regulatory compliance

Leadership

AI/ML experience

Software lifecycle

DevOps

FDA submissions

Risk management

Design Controls

Team coaching

Education

Bachelor's degree in engineering

Advanced degree preferred

Tools

SPDF

Job description

Johnson & Johnson MedTech is seeking a Director of Software Quality Engineering & Cybersecurity for the OTTAVA Robotic Platform in Santa Clara, CA. The role leads software QE and cybersecurity programs for SaMD/MDDS across the lifecycle, partnering with R&D, Regulatory, and enterprise security teams.

The ideal candidate has 12+ years in regulated medical devices, 7+ years in leadership, and deep knowledge of FDA/ISO frameworks, with hands-on AI/ML experience and strong risk management