Senior Software Development Engineer

As a medical device Software Test Engineer in Fresenius Medical Care's Home business unit, you will be able to make a valuable contribution every day to improving the quality of life of our patients of home dialysis therapies with the development of peritoneal dialysis devices. You can expect a dynamic, global, yet familiar environment in which you can master the following challenges:

PURPOSE & SCOPE:

• You are part of an interdisciplinary, cross-functional team in an agile context, which, together with other teams, independently drives the development, testing and maintenance of our innovative product range and thus shapes the future of our therapy systems.

• A high-quality implementation in terms of functional security, testability of individual functions and easy maintainability is your top priority. You create solutions by designing software and software components (esp. in C/C++), developing software requirements from system/product requirements and creating the necessary documentation as a contribution to the analysis of software and cybersecurity risks.

• You develop software requirements from system/product requirements, and design, implement and test them, particularly focusing on the cybersecurity and secure design aspects of a connected ecosystem.

• You ensure quality by developing and executing software tests, especially unit tests and integration tests, and performing code reviews and checking countermeasures. You will also be involved in supporting the development of software system test procedures as part of the verification of software and device functions, as well as performing failure analysis and developer testing as an important part of the challenge.

• Together with your team colleagues, you will be responsible for the technical design of the implementation of new product features as well as the maintenance of existing product variants. In doing so, you will work hand in hand with our product owner as well as with various other functional and technical contacts.

• You have a high interest in the continuous review and improvement of your own work procedures and processes and work this out together with your teammates.

• Iterative-incremental development of software is a welcome approach for you and the basis for customer-centric development of software that creates value.

• You develop your highest creativity in the team, but independent analysis and solving of tricky challenges are also part of your job.

• Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software.

• Maintains effective communication with the project manager, and team members on development scope, timelines, and issues.

• Acts as technical contact in the company to provide decisions and recommendations for secure software design and implementation

• Have a high interest in the continuous review and improvement of your own work procedures and processes and work this out together with your teammates.

REQUIREMENTS

• Successfully completed studies in computer science, computer engineering, electrical engineering, software engineering, medical technology, or similar field of specialization

• Demonstrated understanding of principles, theories and concepts in the software engineering field, preferably in the medical device area.

• Several years of professional experience in (embedded) software development, specifically on connected devices with product security focus

• Experience in cybersecurity activities such as security risk management, requirements elicitation, requirements gap analysis, risk assessment, threat modling, penetration testing, static code analysis, CVE analysis, etc.

• Strong programming experience in C/C++ Experience in scripting languages (Perl, Python) as well as knowledge of agile software development approaches, preferably Scrum desirable

• Experienced in various software testing methodologies (unit testing, integration testing, software system testing, regression testing, etc.)

• Excellent organizational and verbal/written communication skills.

• Strong interpersonal skills with ability to work effectively in a team or individually without supervision.

• Highly motivated and energetic. Passion for creating high quality medical device software and systems.

• Experience and familiarity with IEC 62304 and ISO 13485, and with FDA GMP is highly preferred.

• Experience interfacing with sensors, actuators, pumps, motors and microprocessor/microcontroller is preferred.

• Experience using software configuration management tools such as DevOps, Subversion and Git

• Knowledge regarding requirements for software development in functional safety

• Knowledge regarding the secure (cyber security) development of software

• Structured way of working and good organizational skills

• High degree of reliability and personal responsibility

• Familiarity with German language is a plus, but not required

• Willingness for occasional business trips in the national or international area

PHYSICAL DEMANDS AND WORKING CONDITIONS

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION

• Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS

• 5 - 8 years' related experience;

• Master's degree with >3 years' related experience;

• PhD without experience; or equivalent directly related work experience.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.