Cybersecurity Quality Engineer

Job Summary

The Cybersecurity Quality Engineer supports the integration of cybersecurity requirements into the product development lifecycle and quality management system for Masimo medical device products. Working under the guidance of senior quality, software, and cybersecurity team members, this role assists in ensuring cybersecurity-related activities are documented, traceable, and executed in accordance with applicable regulatory requirements, quality system procedures, and internal standards. This is an early‑career engineering role suited for an individual seeking to develop specialized experience at the intersection of quality systems, design controls, software quality, and medical device cybersecurity.

• Support execution of cybersecurity quality activities across assigned product development programs, including documentation review, milestone tracking, and quality record maintenance.
• Assist in the preparation, review, and maintenance of cybersecurity‑related design control documentation, including threat modeling records, vulnerability assessments, security risk analyses, cybersecurity protocols, and test reports.
• Maintain traceability between cybersecurity requirements, software design outputs, mitigation activities, and verification/validation records within the Design History File (DHF).
• Support authoring, review, and periodic updates of cybersecurity-related quality system procedures, work instructions, templates, and documentation standards.
• Assist in cybersecurity vulnerability monitoring and post‑market surveillance activities, including tracking disclosed vulnerabilities, supporting impact assessments, and documenting remediation activities.
• Support management of cybersecurity-related nonconformances, CAPAs, deviations, and engineering changes through the quality management system, ensuring accurate documentation and timely follow‑up.
• Participate in cross‑functional design reviews, cybersecurity risk reviews, and project meetings, supporting quality representation for cybersecurity-related topics.
• Collaborate with R&D, Software Engineering, Regulatory Affairs, Product Security, and Quality teams to support consistent application of cybersecurity quality requirements across development activities.
• Support preparation of cybersecurity documentation required for audits, regulatory submissions, inspections, and internal quality reviews.
• Assist in evaluation of third‑party software components, open‑source software dependencies, and Software Bill of Materials (SBOM) documentation to support cybersecurity traceability and risk awareness.
• Support internal audits, readiness activities, and documentation reviews related to cybersecurity quality and design control compliance.
• Stay current with evolving regulatory guidance, industry standards, and cybersecurity best practices relevant to medical device development.

• Bachelor’s degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, Software Engineering, or related technical discipline.
• 0–3 years of experience in quality engineering, software quality, cybersecurity, product security, or related engineering field; relevant internship, co‑op, or project‑based experience in regulated environments will be considered.
• Foundational understanding of cybersecurity concepts including vulnerability management, threat modeling, software security, network security, and secure development principles.
• Familiarity with quality systems, design controls, software lifecycle documentation, or regulated engineering processes.
• Strong attention to detail and ability to manage documentation accurately.
• Effective written and verbal communication skills.
• Ability to manage multiple tasks and priorities in a dynamic, cross‑functional environment.

• Exposure to medical device, healthcare technology, embedded systems, or regulated software environments.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related regulatory expectations.
• Awareness of standards such as AAMI TIR
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