Job
In this role, you will take responsibility for the cybersecurity of medical devices through requirements analysis, threat modeling, security architecture, secure software development, and testing to ensure regulatory approvals.
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Your role in the team
- You assume technical responsibility for the cybersecurity of our medical devices throughout the entire product lifecycle - from requirements analysis and threat modeling to security architecture and secure software development, as well as security testing and regulatory approval.
- You continuously develop the cybersecurity strategy for our medical devices and ensure its implementation within product development.
- They gather, analyze, and specify cybersecurity requirements and support their implementation in close collaboration with software development and system engineering.
- They conduct threat modeling and cybersecurity risk assessments and define as well as evaluate appropriate security architectures and security controls.
- They accompany the software and system development with a focus on secure development and support the development teams with complex security issues.
- They plan and oversee the verification & validation of cybersecurity requirements and develop appropriate security test and penetration test plans.
- You coordinate external security and penetration testing service providers, assess identified vulnerabilities and findings, and oversee the derivation and implementation of appropriate remediation measures.
- You create and review cybersecurity-relevant technical documentation and support regulatory approval processes for the European and US markets.
- They contribute to Software Bill of Materials (SBOM), Vulnerability Management, and Post-Market Cybersecurity, thereby supporting continuous product security throughout the entire lifecycle.
- You work closely with internal interfaces such as Software Development, System Engineering, Quality, Risk Management, and Regulatory Affairs.
- You represent cybersecurity topics professionally and confidently to internal stakeholders, auditors, designated bodies, and authorities.
- Furthermore, you will contribute to the maintenance and continuous development of our Secure-Build environment as well as the associated cybersecurity processes.
Our expectations of you
Education
- You have successfully completed a degree in Computer Science, Cybersecurity, Software Engineering, Electrical Engineering, Medical Technology, or a comparable field of study, or possess an equivalent qualification.
Qualifications
- You possess solid knowledge in Security Requirements Engineering, Threat Modeling, Cybersecurity Risk Management, Security Architecture, and Secure Software Development.
- You are familiar with the development of safety-critical or regulated products, ideally from medical technology or a comparable regulated environment.
- You have knowledge of the regulatory cybersecurity requirements for medical devices in Europe and the USA.
- You are familiar with creating and maintaining technical documentation as well as audit and assessment processes.
- You work independently, in a structured and goal-oriented manner, and at the same time bring strong communication and teamwork skills for collaboration in interdisciplinary teams.
- Excellent German and English language skills, both written and spoken, complete your profile.
Experience
- You bring several years of relevant professional experience in the field of software, product, or medical device cybersecurity.
- In addition, you have practical experience with security testing and penetration testing as well as with assessing and addressing vulnerabilities.
- Ideally, you have practical experience with the EU-MDR, the FDA Cybersecurity Requirements, and IEC 81001-5-1.
What we offer
- At Fresenius Medical Care, there are numerous opportunities to actively shape your professional future—regardless of the field you specialize in or your level of professional experience.
- We accompany you on your individual career path and offer you numerous development opportunities.
- Whether directly in treatment or behind the scenes - you make an important contribution to making better medicine accessible to more and more people worldwide.
- Individual opportunities for autonomous career planning and personal development.
- A corporate culture that provides space for innovative ideas and where the best solution is found together – not just the fastest.
- A dedicated team of people with diverse skills, talents, and experiences.
- The advantages of a successful globally operating company combined with the collegial culture of a medium-sized enterprise.
Benefits
Health, fitness & fun
Work-Life-Integration
Food & drink
Topics you will work on
Job locations
About your employer
Fresenius Medical Care is a world-leading provider of dialysis products and therapies. With over 40 years of experience in dialysis and cutting-edge research, we offer our patients the best possible treatment.
- Established Company
- Hybrid, Onsite
- Pharmaceutical Sector, Chemical Industry, Biotech
Employer reviews
- Working conditions
- 4.3
- Engineering
- 3.0
- Career growth
- 3.0
- Team culture
- 3.5
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