Systems Engineer II
16 hours ago
The Systems Engineer II will play a pivotal role in supporting the design, development, testing, and documentation of dialysis instruments at Fresenius Medical Care North America.
This individual will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment, supporting systems engineering related activities on product development programs.
Key Responsibilities:- Support systems engineering efforts for complex, software-driven medical devices, including managing parts flow, systems builds, software loads and updates, configuration control, and test execution and reporting.
- Collaborate with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a home dialysis instrument.
- Support the development and maintenance of product specifications, requirements documents, hazards analysis documents, usability and V&V documentation, and other technical documentation.
- Conduct Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
- Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
- Work with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
- Provide technical guidance for product design, development, integration, testing, and reliability improvements.
- Owns and drives resolution of design issues/defects, under guidance from senior R&D engineers.
- Performs product tests to conform compliance to regulatory standards.
BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred.
2+ years experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred.
Understanding of medical device product design and regulatory processes.
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, electronics, mechanical and software integration.
Knowledge of design of experiments.
Technical understanding of and experience with best-practice product development methodologies.
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Systems Engineer II
2 days ago
Lawrence, Kansas, United States Fresenius Medical Care Holdings, Inc. Full timeJob Title: Systems Engineer IIFresenius Medical Care North America is seeking a highly skilled Systems Engineer II to join our team. As a key member of our engineering team, you will play a critical role in supporting the design, development, testing, and documentation of dialysis instruments.Key Responsibilities:Support systems engineering efforts for...
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Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full timePurpose and ScopeThe Systems Engineer II will play a pivotal role in supporting the design, development, testing, and documentation of dialysis instruments at Fresenius Medical Center.This individual will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment, supporting systems engineering related activities on product...
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