Cybersecurity Quality Engineer

Job Summary

Duties & Responsibilities

Minimum Qualifications

Preferred Qualifications

Compensation

Benefits

Physical Requirements/Work Environment

• Support execution of cybersecurity quality activities across assigned product development programs, including documentation review, milestone tracking, and quality record maintenance.
• Aid 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).
• Aid in the authoring, review, and periodic updates of cybersecurity-related quality system procedures, work instructions, templates, and documentation standards.
• Support vulnerability monitoring and post-market surveillance activities, including tracking disclosed vulnerabilities, supporting impact assessments, and documenting remediation activities.
• Aid in managing 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.
• Aid in the preparation of cybersecurity documentation required for audits, regulatory submissions, inspections, and internal quality reviews.
• Aid in evaluating third-party software components, open-source software dependencies, and Software Bill of Materials (SBOM) documentation to support cybersecurity traceability and risk awareness.
• Aid in 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.

Minimum & Preferred Qualifications and Experience:

• 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.

Preferred Qualifications:

• 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.

Education:

• Bachelor’s degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, Software Engineering, or related technical discipline, or equivalent combination of education and experience.

Compensation:

• The anticipated salary range for this position is $85,000 - $105,000.
• Actual placement within the range is dependent on multiple factors, including but not limited to skills, experience and internal equity.
• This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Benefits:

• Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center.

Physical Requirements/Work Environment:

• This position primarily works in an office environment and requires frequent sitting, standing, and walking.
• Daily use of a computer and other digital devices is required.
• This role may require standing for extended periods when facilitating meetings, supporting laboratory activities, or walking through facilities.
• Must be able to move throughout office, laboratory, and light manufacturing environments as needed to support design reviews, product inspections, audits, and cross-functional collaboration.
• Occasional lifting and carrying of materials or equipment up to 25 lbs. may be required.
• Domestic and international travel up to 20–25% may be required to support supplier visits, audits, customer activities, or program-related meetings.