Product Security Expert in a hybrid role focusing on cybersecurity implementation for medical devices at Fresenius Medical Care in Germany. Collaborating with cross-functional teams to enhance product security.
Responsibilities
Execution of the Product Security Program
Maintain and continuously update the Cybersecurity Risk Register for all products in the portfolio
Execute the Post-Market Surveillance process for cybersecurity, including analysis of security-related complaints, incidents, and vulnerabilities
Operate the Coordinated Vulnerability Disclosure and Incident Response process, including triage, coordination, tracking, and documentation.
Act as the primary coordinator for product-related cybersecurity activities, working closely with R&D and system engineering teams to ensure secure product development
Contribute to the development and rollout of cybersecurity-related policies, SOPs, and guidelines, ensuring alignment with the overall QMS and evolving regulatory requirements
Define and maintain Cybersecurity Management Plans and Security Verification Plans for CE products throughout the development lifecycle
Support Security Risk Management activities, including threat and risk analysis, countermeasure definition, and evaluation of residual cybersecurity risks
Support the preparation of risk/benefit assessments for cybersecurity risks to enable informed decision-making and documentation
Collaborate in product roadmap planning, contributing cybersecurity input and supporting alignment with the state of the art in security technologies and practices
Requirements
Successfully completed bachelor’s or master’s degree in computer science, information technology or similar field
At least 5 years of professional experience in IT Security, cybersecurity (e.g. embedded systems, risk management, regulatory requirements)
In-depth knowledge of enabling technologies and technical solutions in the field of cybersecurity
Experience in R&D in medical devices or other industries with international exposure
Solid knowledge of the whole development cycle for products from regulated industries
Knowledge of relevant cybersecurity regulations and guidelines such as (FDA pre-market and post-market guidance, Section 2.4b CFR, IEC 81001-5-1, IEC 62443-4-1, JSP 2.0)
Relevant cybersecurity certifications are an advantage
Knowledge of cybersecurity relevant tools (e.g. Microsoft Threat Modelling Tool, BlackDuck Binary Analysis Tool, Kali Linux)
Good and professional relationship to and communication with international colleagues and superiors
Fluent English, in written and spoken, German language is a plus.
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