JOB TITLE: Systems Engineer - Software
REPORTS TO: R&D Manager
JOB PURPOSE: Technical Development Engineer (m/w)– Medical Devices
This position is responsible for defining Systems and Architecture for the next generation of Endoscopy reprocessing software products. The activities will encompass all aspects of systems & software engineering activities, meeting all regulatory standards, to realize complex, innovative, high reliability systems that improve the quality of life of people around the world.
The Senior Systems Engineer is responsible for providing overall systems design & architecture across complex electro-mechanical systems with embedded firmware and connectivity for Automated Endoscope Reprocessors (AER) in MEDIVATORS medical device segment.
- Development of Systems Architecture, Software Design, Hardware interface and Connectivity solutions for medical grade software.
- Define Requirements and Design specifications in collaboration with upstream Marketing, Standards bodies and Regulatory requirements.
- Create Architectural Design for developing software in C#, ASP.NET MVC, WPF & XAML, Entity Framework, with MS SQL Server interface.
- Developing of platform software definition with microcontrollers, WiFi, Bluetooth and RFID technologies.
- Creates Architectural Designs and prototype models for Proof of Concept and feasibility.
- Execute on meeting deliverables in accordance with New Product Development Phase Gate process.
- Develop plans for Human Factors Engineering and Usability Testing and coordinate execution by identifying and engaging key clinical personnel from internal groups and customer sites.
- Collaborate with Regulatory Affairs, Technical Services, and Manufacturing/Operations for hitting key milestones for New Product Development in alignment with R&D objectives and product direction.
- Execute Qualification Protocols and Test execution across all aspects of Firmware and Software, including over Systems Validation, to ensure that the product meets requirements.
- Create and document all aspects of the software engineering processes for products, incorporating the highest quality standards in accordance with the QMS, cost effectiveness, and measurable efficiency.
- Provide technical support for software deployment at Beta sites and work closely with Technical services group for troubleshooting and making enhancements.
- Lead and provide guidance in the development & testing of prototypes, verification/validation units and product specifications, including test development plans, test reports and input to risk analysis.
- Establish and perform or oversee the execution of software test plans, assess device limitations and determine acceptance criteria.
- Provide an effective bridge between software and hardware personnel and be responsible for the timely completion of the technical deliverables.
- Provide support to Marketing for Voice of Customer and new product launches in US and Europe.
- Bachelor’s degree in computer science, electrical engineering or a related field
- At least 5 years’ experience in the development of object-oriented software
- Systems Engineering experience for designing with technologies - C#, .NET MVC, .Net CF, WPF & XAML, Entity Framework & SQL Server.
- Provide technical expertise in Endoscope reprocessing technologies and Trace and Track systems, in accordance with IEC and AAMI standards, e.g. IEC 19505 and IEC 62304
- Experience with the development of medical devices
- Familiar with Design Controls, AAMI and ISO standards.
- Knowledge of the processes in hospitals, especially reprocessing, are beneficial
- Analytical thinking and approach
- Must have excellent written and verbal communication skills in the German and English languages
- Ability to work successfully both independently and in a team environment.
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