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Staff Engineer

freseniuskidneycare.com Logo

Fresenius Kidney Care Eupora

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Location:
United States of America , Lawrence

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

131000.00 - 220000.00 USD / Year
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Job Description:

We are looking for a highly technical Staff Systems Engineer who will play a key role in the design and development dialysis instruments at NxStage Medical. He or she will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will lead systems engineering related activities on product development programs, exhibiting outstanding verbal and written communication skills.

Job Responsibility:

  • 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
  • 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
  • Leads the development of algorithms, test plans, processes, test fixtures, data acquisition capabilities, etc., in support of ongoing product development as well as informal and formal testing of complex electro-mechanical, software-driven medical devices
  • 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

Requirements:

  • Bachelor’s Degree in related engineering Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field)
  • MS/PhD preferred
  • 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
What we offer:
  • medical insurance
  • dental insurance
  • vision insurance
  • 401(k) with company match
  • paid time off
  • parental leave
  • potential for performance-based bonuses depending on company and individual performance

Additional Information:

Job Posted:
April 23, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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