Lead Product Cybersecurity Architect – Medical Devices

Fresenius Kabi USA, LLC; Manchester (NH); Vor Ort; USD 145.000 - 155.000; Vollzeit

Benefits dieser Stelle

401(k) plan with company contributions

Health benefits (medical, dental, VIS)

Paid vacation, holidays and personal/s

Zusammenfassung

Fresenius Kabi USA, LLC is seeking a Sr. Principal Engineer, Product Cybersecurity to advance secure development practices across medical device software and connected platforms.

You will lead security architecture, risk management, threat modeling, and DevSecOps while mentoring teams and guiding strategic technical decisions. Salary ranges from $145,000 to $155,000 based on experience, with a target 10% bonus.

Qualifikationen

• Bachelor's degree in Computer Science, Computer Engineering, Cybersecurity or related Engineering is required.
• 8+ years of experience in cybersecurity, software engineering, product security, or a related technical discipline, including experience applying cybersecurity practices to software-based products.
• Experience applying FDA cybersecurity guidance, IEC 81001-5-1, IEC 62304, ISO 14971, and related cybersecurity standards within regulated medical device development environments.
• Experience conducting cybersecurity risk assessments and supporting risk management activities in accordance with ISO 14971.
• Experience with vulnerability assessment and management, SBOM governance, security analysis, and threat modeling is required.
• Experience supporting FDA submissions and regulatory audits is highly desired
• Experience applying cybersecurity principles to embedded medical device software and/or web applications.
• Experience in planning and execution of cybersecurity penetration testing activities.
• Experience with Static Analysis (SAST), Dynamic Analysis (DAST), and Software Composition Analysis (SCA).
• Ability to work as a collaborative team member.
• Advanced in problem solving, analytical, troubleshooting, and debugging skills.
• Strong attention to details, natural inclination to be methodical.
• Excellent in written and verbal communication skills
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Aufgaben

• Guides the conceptualization of new secure methodologies while identifying improvements for processes and best practices in product cybersecurity for all aspects of the IMS and LVP products.
• Develops and implements cybersecure solutions to complex problems using multiple disciplines and technical principles.
• Analyzes, plans, designs, executes, and documents the security of highly complex software applications and/or processes within established medical product design controls.
• Plans and performs security testing through manual and automated means for new features, enhancements, and defect fixes across multiple software subsystems.
• Leads secure design reviews, security requirements definition, and security architecture reviews, providing technical direction for authentication, authorization, encryption, secure communications, key management, cloud security, and secure software design patterns.
• Participates in operational cybersecurity activities including Coordinated Vulnerability Disclosure (CVD), PSIRT processes, vulnerability investigations, and post-market cybersecurity activities.
• Develops and maintains product threat models using methodologies such as STRIDE, attack trees, abuse cases, and adversarial analysis techniques.
• Develops, reviews, and maintains cybersecurity standard operating procedures and provides recommendations for continuous process improvements to maintain compliance with global regulatory standards and agency regulations. Conducts ongoing vulnerability scanning and risk evaluations.
• Supports and advances Secure Software Development Lifecycle (Secure SDLC) practices across product development teams.
• Drives implementation of DevSecOps practices including automated security testing, policy enforcement, SBOM generation, vulnerability management, and secure CI/CD pipelines.
• Provides guidance on secure coding practices and remediation of cybersecurity vulnerabilities throughout the software development lifecycle.
• Works with senior leadership to improve cybersecurity engineering process efficiency. Works with global internal and external staff to identify cybersecurity coverage needs, high-risk areas, and to improve overall software cybersecurity and robustness.
• Mentors and guides junior staff, routinely provides technical input on architecture and design decisions to improve cybersecurity, while remaining a hands‑on individual contributor within the development team. May supervise or direct lower‑level engineers on assigned projects.
• Develops and maintains technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Kenntnisse

Cybersecurity

Software security

Threat modeling

DevSecOps

Risk management

Regulatory compliance

Debugging

Communication

Team leadership

Mentoring

Ausbildung

Bachelor's degree in Computer Science/Engineering

Tools

SAST tools

DAST tools

SCA tools

SBOM management tools

Jobbeschreibung

Fresenius Kabi USA, LLC is seeking a Sr. Principal Engineer, Product Cybersecurity to advance secure development practices across medical device software and connected platforms.

You will lead security architecture, risk management, threat modeling, and DevSecOps while mentoring teams and guiding strategic technical decisions. Salary ranges from $145,000 to $155,000 based on experience, with a target 10% bonus.