Staff Engineer, Systems Engineer

* Leads the development and maintenance of system architecture, product specifications, requirements documents, build instructions, acceptance test specifications, V&V documentation, and other technical documentation.
* Provides technical leadership for product development, integration, testing, and reliability improvements.
* Leads modeling-based design and development and systems engineering activities. Work with experts across Fresenius Medical Care to integrate new tools into design and development process.
* Leads a team of engineers and technicians to support product development as well as V&V activities in support of a regulatory filing.
* Maintain knowledge of state-of-the-art principles, theories, and practices around all systems engineering related activities. Identify and recommend long-term tools, standards, and methods to drive continual systems engineering improvement.
* Leads the development of algorithms, test plans, processes, test fixtures, data acquisition capabilities, etc., in support of on going product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing parts flow, systems builds (including hardware assembly and integration), software loads and updates, configuration control, and test execution and reporting.
* Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF).
* Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
* Participates in Risk Management activities (including FMEA, FTA, OMA, etc.) to ensure that design and process needs are identified and appropriately addressed.
* Creates and reviews process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
* Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
* Role may include management responsibility for a team of engineers, programmers, technicians, and/or coops; responsibilities may include planning and directing / supervising employee activities, reviewing employee performance, identifying and supporting employee career development needs, etc.
* 10+ years experience in Medical Device
* Strong understanding of medical device product design and regulatory processes.
* Hands-on experience with modeling-based design and development and Modeling Based System Engineering (MBSE)
* Experience with using MBSE tools such as Catia/No Magic and Simulink/MATLAB
* Able to communicate effectively, both verbally and in writing.
* Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
* Strong understanding of system design, electro-mechanical systems, electronics, mechanical and software integration.
* Systems engineering experience (design product architecture development, requirements & specification development, risk management, V&V testing)
* Knowledge of design of experiments, six-sigma, and other statistics-based testing methodologies.
* Technical understanding of and experience with best-practice product development methodologies
* Experience with model based Systems Engineering and lifecycle management tool such as Enterprise Architect Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.

We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.
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