Position Summary:
Take a key role in developing and improving NxStage’s products. This individual will apply sound engineering principles to the development of new products and will be involved in all parts of a product’s life, from feasibility evaluation for new features and products to improving the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for supporting a specific product line. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to issues, completing projects, and launching new products.
Responsibilities:
Collaborate with systems, electrical, disposable, and software engineers to create, test, and improve complex electro-mechanical components and assemblies for next generation home dialysis instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, and PCBA mounting/cabling
Analysis of mechanical systems, including geometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acoustics
Develop manufacturing drawings in accordance with applicable standards
Construct and test / oversee technicians in constructing and testing of prototype systems
Troubleshoot new designs and/or develop reliability improvements for existing designs
Improve designs for reliability, manufacturability, and performance
Participate in the development of product specifications and requirements documents
Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design- and process- related risks are identified and appropriately mitigated
Work with Quality Assurance to maintain documentation in accordance with the approved internal Quality System that meets applicable GMP, QSR, ISO13485, and other requirements
Support the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipment
Manage vendors to insure rapid delivery of prototype components
Skills:
Proficient in Solidworks 3D modeling, standard analysis tools and methodologies, mechanical detailing, geometric tolerance analysis, and documentation is preferred
Strong understanding of medical device development processes
Able to communicate effectively, both verbally and in writing
Strong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysis
Experience maintaining the confidentiality of sensitive information
Experience with design of experiments
Familiarity with fabrication methods such as machining, molding, sheet metal, and casting processes
Demonstrated aptitude for practical application of mechanical, pneumatic, and electrical to system design. Design for EMI/ESD.
Minimum Requirements:
BS in Mechanical Engineering, MSME is a plus
5+ years of experience in product design, development, and/or testing of complex electro-mechanical products
Prior medical device experience strongly preferred
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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About 3.5 million patients worldwide depend on regular dialysis treatment. Fresenius Medical Care is committed to enabling a future worth living for these people. Our teams in Research and Development, operating in 23 locations across three regions, are responsible for the ongoing development of the medical products and treatments required across the renal care spectrum.
We drive research on innovative dialysis devices and turn it into reality. To deliver solutions that are continuously optimized and tailored to meet patients’ specific needs, we develop IoT-supported diagnostic methods and evidence-based, individualized treatments. Our integrated, multidisciplinary approach to research and development speaks to specialists as well as generalists.
Discover the benefits of joining a global organization that is committed to excellence and quality. We support your career journey by helping you fulfill your ambitions. That’s how we create value for our patients and our employees.
As market leader, Fresenius Medical Care sets new, higher standards in dialysis. Help us define them: become part of a talented team that drives innovation in health care. Join our scientists and professionals in delivering excellence on a global scale.
We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.
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