Director Software Quality Engineering & Cybersecurity

About the role

The Director leads the quality engineering strategy and execution for software-enabled medical technologies across the OTTAVA robotic surgical platform. This role partners closely with R&D, Regulatory Affairs, Medical Safety, Systems Engineering, Clinical, and enterprise cybersecurity teams to ensure software products and supporting systems meet global regulatory requirements, cybersecurity expectations, and company quality standards throughout the product lifecycle.

Responsibilities

• Lead the Software Quality Engineering function supporting the OTTAVA robotic surgical platform and associated digital technologies.
• Establish and execute software quality strategies aligned with FDA, ISO 13485, IEC 62304, ISO 14971, FDA cybersecurity guidance, and applicable global regulations.
• Provide oversight of software design controls, software lifecycle processes, software risk management, anomaly management, configuration management, and release readiness activities.
• Ensure robust traceability between software requirements, hazards, mitigations, verification, validation, and cybersecurity controls.
• Lead quality and compliance activities for Software as a Medical Device (SaMD) and Medical Device Data Systems (MDDS).
• Partner with Regulatory Affairs to support regulatory submissions, FDA interactions, technical documentation, and cybersecurity deliverables.
• Ensure software classification, intended use, and regulatory positioning are appropriately documented and maintained.
• Lead quality oversight for product cybersecurity activities across the software development lifecycle.
• Partner with enterprise cybersecurity and product security teams to ensure implementation of Secure Product Development Framework (SPDF) practices.
• Oversee cybersecurity risk management, vulnerability management, penetration testing assessments, SBOM governance, threat modeling, and post-market cybersecurity processes.
• Ensure cybersecurity activities are integrated into CAPA, complaint handling, supplier controls, and change management systems.
• Support regulatory responses related to cybersecurity and software assurance.
• Establish and maintain compliant validation programs for non-product software used in development, testing, manufacturing, quality systems, and operations.
• Ensure validation approaches are risk-based, scalable, and inspection-ready.
• Oversee governance for software tools supporting regulated activities, including lifecycle management and change control.
• Partner with R&D and Systems Engineering to support new product development, sustaining engineering, design changes, and software releases.
• Participate in risk management activities, design reviews, verification/validation reviews, and failure investigations.
• Ensure software quality considerations are integrated into design transfer and launch readiness activities.
• Develop and maintain procedures, standards, and governance models supporting software quality and cybersecurity compliance.
• Ensure inspection readiness for FDA, notified body, and internal audits.
• Lead software quality metrics, trend analysis, and continuous improvement initiatives.
• Support investigations, CAPAs, complaints, and field actions involving software or cybersecurity-related issues.
• Build and develop a high-performing Software QE organization.
• Provide coaching, mentorship, and career development for managers and engineers.
• Foster a culture of accountability, technical excellence, collaboration, and proactive risk management.
• Drive clarity of ownership and effective cross-functional decision-making.
• Leads with technical credibility and executive presence, inspiring confidence across engineering, operations, and executive teams.
• Comprehensive understanding of Design Controls, Design Verification and Validation, and Design Transfer processes for medical devices.
• Proficiency with 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR compliance frameworks.
• Proven success supporting FDA inspections, ISO certification audits, and MDSAP assessments with strong command of global regulatory requirements.

Qualifications/requirements

• Bachelor’s degree in engineering, Computer Science, Software Engineering, Biomedical engineering, or related technical field is required. Advanced degree is preferred.
• A minimum of 12 years of experience in medical devices, software-regulated, or highly regulated industries.
• A minimum of 7 years of leadership experience managing software quality or software engineering teams.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, FDA QSR/QMSR, and FDA cybersecurity guidance.
• Hands-on experience with AI/ML-enabled device development, software lifecycle management, and digital health quality integration.
• Experience with software risk management, cybersecurity governance, and software development lifecycle processes.
• In depth knowledge of SPDF, threat modeling, SBOM management, and vulnerability assessment processes.
• Experience with Agile software development environments and DevOps methodologies.
• Experience supporting FDA submissions, inspections, and regulatory audits.
• On-site attendance at Johnson and Johnson robotic campus in Santa Clara, CA facility is required for at least 3 days a week.

Preferred Skills

• Business Planning
• Change Management
• Coaching
• Cybersecurity
• Design Controls
• Fact-Based Decision Making
• FDA Submissions
• Give Feedback
• Inclusive Leadership
• Leadership
• Process Improvements
• Risk Management
• Software
• Science
• Technology
• Engineering
• Math (STEM)
• Application
• Technical Software