Director, Software Quality & Cybersecurity (MedTech)

6267-Auris Health Inc. Legal Entity

Santa Clara (CA)

On-site

USD 172,000 - 298,000

Full time

3 days ago

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Benefits offered by this job

Vacation 120 hours/year

Pension

401(k)

Long-term incentive program

Job summary

Johnson & Johnson MedTech in Santa Clara, CA seeks a Director to lead Software Quality Engineering and Cybersecurity for the OTTAVA robotic platform. You will own software quality strategies, lifecycle, and risk management, ensuring regulatory compliance and safe product commercialization.

On-site attendance is required at least 3 days a week. You will collaborate with R&D, Regulatory, and cybersecurity teams to align with FDA guidance and ISO standards, driving excellence and inspection

Qualifications

Bachelor’s degree in engineering, CS, software engineering, biomedical engineering, or related field.
Advanced degree preferred.
Minimum 12 years in medical devices or highly regulated industries.
Minimum 7 years in leadership of software quality or software engineering teams.
Hands-on with AI/ML-enabled device development, software lifecycle, and cybersecurity.
Experience with FDA submissions, inspections, and regulatory audits.

Responsibilities

Lead Software Quality Engineering for the OTTAVA robotic platform and digital tech.
Ensure software quality strategies align with FDA, ISO 13485, IEC 62304, ISO 14971.
Oversee software design controls, lifecycle, risk management, and cybersecurity controls.
Partner with Regulatory Affairs for regulatory submissions and cybersecurity deliverables.
Lead QA governance, SPDF adoption, threat modeling, and vulnerability assessments.
Drive inspection readiness and continuous improvement across software quality.