Job Summary:
Masimo Wearables is a company focused on medical device products, and they are seeking a Cybersecurity Quality Engineer. This early-career role involves supporting the integration of cybersecurity requirements into the product development lifecycle and ensuring compliance with regulatory and quality management standards.
Responsibilities:
• 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.
Qualifications:
Required:
• 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.
• Ability to read, write, and communicate effectively in English.
• Ability to interpret technical documents, engineering data, schematics, and written procedures.
• Ability to clearly document technical findings and effectively communicate across cross-functional teams.
Preferred:
• 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 TIR57, IEC 62304, IEC 81001-5-1, or NIST cybersecurity frameworks.
• Exposure to Software Bill of Materials (SBOM), software traceability, or software quality documentation practices.
• Foundational knowledge of software validation, software quality assurance, or secure SDLC practices.
• Security+, ISC2 CC, or similar entry-level cybersecurity certification is a plus.
Company:
The Masimo Freedom™ smartwatch empowers individuals to take control of their personal health through accurate and continuous health tracking. Founded in , the company is headquartered in , , with a team of 10001+ employees. The company is currently Late Stage.