d) at Fresenius Medical Care

Sailauf, Bavaria, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Successfully completed bachelor’s or master’s degree in computer science, information technology or similar field of specialization
Minimum 5 years of professional experience in IT Security, cybersecurity (e.g. embedded systems, risk management, regulatory requirements) with in-depth knowledge of enabling technologies and technical solutions in the field of cybersecurity
Ideally experience in R&D in medical devices or other industries with international exposure and heavy regulated environments (e.g.: medical, automotive, d&s, nautical, avionics)
Knowledge of relevant cybersecurity regulations and guidelines (FDA pre-market and post-market guidance, section 2.4b CFR, IEC 81001-5-1, IEC 62443-4-1, JSP 2.0)
Knowledge of R&D related processes and methodologies (e.g. cybersecurity, product risk management, etc.)
Experience in embedded systems development is an advantage
Knowledge of relevant software quality regulations and guidelines such as IEC 62403, IEC 82304 is an advantage
Knowledge of cybersecurity relevant tools (e.g. Microsoft Threat Modelling Tool, Binary Analysis Tools, Static code analyzers)

Responsibilities

Provide hands-on security engineering support across the Water Systems product family, including embedded controllers, IoT components, and connected digital services
Partner with R&D to integrate cybersecurity controls early in the development lifecycle, including, but not limited to secure boot, encrypted communication, and access control mechanisms
Perform security design reviews, support code-level mitigation efforts, and contribute to validation of security features for WTS products and related platforms
Serve as the technical point of contact for security topics related to WTS products, connectivity modules, and system interfaces
Contribute to the operational execution of the Product Security Program within the assigned portfolio, ensuring alignment with internal frameworks and regulatory requirements (e.g., FDA, MDR, IEC 81001-5-1)
Support vulnerability handling and coordinated disclosure processes, including triage, remediation tracking, and external communication preparation
Participate in post-market surveillance of cybersecurity issues, including analysis of incidents and integration of lessons learned into the development process
Maintain product-specific cybersecurity documentation, metrics, and audit-ready records
Develop and maintain cybersecurity plans (e.g., Cybersecurity Management Plan) throughout the product lifecycle
Perform or support threat modeling, attack surface analysis, and cybersecurity risk assessments in accordance with regulatory expectations and internal documentation
Assist in defining risk mitigations and evaluating residual risks to support design decisions and regulatory justifications
Contribute security input to product roadmaps, change impact assessments, and submission dossiers
Participation in medical device cybersecurity events/conferences

Skills

Cybersecurity

Secure Boot

Encrypted Communication

Access Control

Security Design Review

Vulnerability Handling

IoT Security

Embedded Systems

IEC 81001-5-1

FDA Regulations

MDR

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees