Principal Cybersecurity Engineer
Fresenius Kabi15 days ago
North Andover, MA, USAStaff+
Base Salary
$145k - $155k/yr
Responsibilities
- Advance secure product development practices across medical device software and connected technology platforms.
- Develop and implement cybersecurity solutions for complex software applications and processes within medical product design controls.
- Lead secure design reviews, security requirements definition, security architecture reviews, and secure coding guidance.
- Plan and perform manual and automated security testing for new features, enhancements, and defect fixes.
- Provide technical direction for authentication, authorization, encryption, secure communications, key management, cloud security, and secure software design patterns.
- Manage coordinated vulnerability disclosure, PSIRT processes, vulnerability investigations, and post-market cybersecurity activities.
- Develop and maintain threat models using STRIDE, attack trees, abuse cases, and adversarial analysis.
- Drive Secure SDLC and DevSecOps practices, including automated security testing, policy enforcement, SBOM generation, vulnerability management, and secure CI/CD pipelines.
- Conduct vulnerability scanning, risk evaluations, penetration testing activities, and cybersecurity risk management.
- Maintain cybersecurity procedures, technical records, documentation, and compliance with global regulatory standards.
- Mentor junior staff, guide engineering teams, and provide technical input on architecture and design decisions.
- Identify cybersecurity coverage needs and high-risk areas with internal and external stakeholders.
Requirements
- Bachelor’s degree in Computer Science, Computer Engineering, Cybersecurity, or a related engineering field.
- 8+ years of experience in cybersecurity, software engineering, product security, or a related technical discipline, including cybersecurity practices for software-based products.
- Experience applying FDA cybersecurity guidance, IEC 81001-5-1, IEC 62304, ISO 14971, and related cybersecurity standards in regulated medical device development.
- Experience conducting cybersecurity risk assessments and supporting ISO 14971 risk management activities.
- Experience with vulnerability assessment and management, SBOM governance, security analysis, and threat modeling.
- Experience applying cybersecurity principles to embedded medical device software and/or web applications.
- Experience with on-premises and cloud-based systems, web applications, APIs, containerized workloads, and hybrid architectures.
- Experience planning and executing cybersecurity penetration testing activities.
- Experience with Static Analysis (SAST), Dynamic Analysis (DAST), and Software Composition Analysis (SCA).
- FDA submission and regulatory audit experience is highly desired.
- Strong problem-solving, analytical, troubleshooting, debugging, collaboration, attention to detail, and communication skills.
- Effective English speaking, reading, writing, and comprehension skills are required.
Benefits
- Salary range of $145,000-$155,000 based on experience.
- Eligible to participate in a bonus plan with a target of 10% of base salary.
- 401(k) plan with company contributions.
- Medical, prescription drug, dental, and vision coverage.
- Paid vacation, holidays, and personal days.
- Employee assistance program, life insurance, disability coverage, and wellness program.
- Employment is at-will and is not guaranteed or permanent.
Categories
About Fresenius Kabi
Fresenius Kabi develops and manufactures injectable generics, infusion therapies, clinical nutrition, biosimilars, and medical devices for hospitals, clinics, and blood banks. It operates in more than 100 countries as an operating company of the Fresenius Group, with headquarters in Bad Homburg, Germany. The company sells pharmaceuticals, medical nutrition, and MedTech products to healthcare providers and distributors serving critically and chronically ill patients.