Cybersecurity Quality Engineer (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Cybersecurity Quality Engineer (MedTech): Supporting the integration of cybersecurity requirements into the product development lifecycle for medical devices with an accent on documentation, traceability, and regulatory compliance. Focus on maintaining design history files, performing vulnerability assessments, and collaborating with cross-functional teams to ensure secure development standards.
Location: Must be based in Irvine, CA, United States
Salary: $85,000 - $105,000
Company
is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies and medical devices.
What you will do
- Support cybersecurity quality activities across product development programs including documentation and milestone tracking.
- Maintain traceability between cybersecurity requirements, design outputs, and verification records within the Design History File.
- Assist in vulnerability monitoring, post-market surveillance, and impact assessments.
- Manage cybersecurity-related nonconformances, CAPAs, and engineering changes within the quality management system.
- Participate in cross-functional design reviews and cybersecurity risk assessments.
- Evaluate third-party software components and Software Bill of Materials (SBOM) for risk awareness.
Requirements
- Bachelor’s degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, or Software Engineering.
- 0–3 years of experience in quality engineering, software quality, or cybersecurity.
- Foundational understanding of vulnerability management, threat modeling, and secure development principles.
- Familiarity with quality systems, design controls, and regulated engineering processes.
- Ability to work onsite in Irvine, CA.
- Effective written and verbal communication skills in English.
Nice to have
- Exposure to medical device standards such as FDA 21 CFR Part 820, ISO 13485, or IEC 62304.
- Knowledge of NIST cybersecurity frameworks or AAMI TIR57.
- Security+ or ISC2 CC certification.
Culture & Benefits
- Comprehensive health benefits including Medical, Dental, and Vision insurance.
- 401(k) retirement plan with company contributions.
- Paid vacation, sick leave, and holidays.
- On-site wellness clinic, fitness center, and café.
- Support for professional growth in a regulated, high-impact industry.
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