Job
- Level
- Experienced
- Location
- Heilbronn
- Working Model
- Onsite
- Job Field
- IT, Security
- Employment Type
- Full Time
- Contract Type
- Permanent employment
Job Summary
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.
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.
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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.
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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.
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Benefits
Higher Take-Home Pay
- 🏝️Summer and Christmas Bonus
- 🍰Employee Stock Option
- 👴🏻Company Retirement Provision
- 👷♂️Additional Insurance
Health, Fitness & Fun
Work-Life-Integration
Food & Drink
Topics You Will Work On
Job Locations
About Your Employer
Fresenius Medical Care AG & Co. KGaA
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.
Description
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech
Employer reviews
by devworkplaces.com
Total
(2 Reviews)3.4
Workingconditions
4.3Engineering
3.0Career Growth
3.0Culture
3.5
Software Security Expert
- Location
- Heilbronn
- Working Model
- Onsite
- Diversity
- Open for all genders
