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:

• 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.
• You will work as a team member to design, develop and modify Software Integration and Software System Test plans, protocols and reports for multiple projects by analyzing software requirements and following the appropriate software development process.
• Ensure quality by developing and executing software test protocols, especially software integration tests and software system test protocols for medical device embedded software.
• Participates in software verification plans and protocol reviews and other related design reviews.
• Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software.
• Creates, identifies, validates, and uses test tools that facilitate data gathering and test method execution.
• Participates in the design, build, validation and deployment of effective test automation solutions.
• Understands defect management and works closely with Software Engineers on defect resolution.
• Maintains effective communication with the team lead, and team members on testing scope, timelines, and issues.
• 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.
• Other duties as assigned, not limited to: 

• Responsible for lab layout and expansion 
• Conduct, track, and document defect investigations 
• Build test bench and test fixtures 
• Handle material purchasing and lab inventory management 
• Hands-on prototype assembly, testing, data analysis 
• Trouble shooting electronic circuitry, hydraulic, and/or pneumatic systems 
• Python scripting 
• Conduct and report on Engineering Tests 

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.
• Software quality assurance experience in a product development environment
• Experience in scripting languages (Python, Perl) 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.)
• Experience with C, embedded processing and I/O control is preferred
• Experience using tools to test and troubleshoot software applications.
• 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 in development of automated test scripts is preferred.
• 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.
• Familiar with 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:

• 2 - 5 years' related experience.
• Master's degree with industry experience.
• PhD Degree with Postdoctoral related 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.