Current jobs related to Senior Design Assurance Engineer - Lawrence, Kansas - FRESENIUS MEDICAL CENTER

  • Senior Software Engineer

    3 weeks ago

    Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full time

    Job Summary:We are seeking a highly skilled Senior Software Engineer to join our team at Fresenius Medical Center. The successful candidate will be responsible for leading the design, development, and testing of software for our life-extending and lifesaving systems.The ideal candidate will have a strong background in software development, with experience in...

  • Senior Project Engineer

    3 weeks ago

    Lawrence, Kansas, United States Bartlett & West Full time

    Job SummaryBartlett & West is seeking a highly skilled Senior Project Engineer to join our team. As a Senior Project Engineer, you will be responsible for designing civil engineering projects, including transportation infrastructure. You will work closely with project managers to identify and develop project scope, meet customer expectations, and ensure...

  • Senior Systems Engineer

    4 weeks ago

    Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full time

    Purpose 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...

  • Transportation Senior Project Engineer

    3 weeks ago

    Lawrence, Kansas, United States JEO Consulting Group Full time

    Job OverviewJEO Consulting Group is a leading multidisciplinary firm that values great work-life integration and a relaxed, supportive, and inclusive environment. Our Transportation Department provides expertise and services including traffic engineering, transportation planning, roadway and bridge design, and environmental services.This position is...

  • Senior Disposables Engineer

    4 weeks ago

    Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full time

    Job SummaryWe are seeking a highly skilled Senior Disposables Engineer to join our team at Fresenius Medical Center. As a key member of our product development team, you will be responsible for designing and developing medical devices that meet the highest standards of quality and safety.Key Responsibilities:Develop and maintain product specifications and...

  • Mechanical Design Engineer

    4 weeks ago

    Lawrence, Kansas, United States Actalent Full time

    Job Title: Mechanical Design EngineerActalent is seeking a skilled Mechanical Design Engineer to join our team. As a Mechanical Design Engineer, you will be responsible for designing and developing HVAC and plumbing systems for industrial and commercial buildings.Key Responsibilities:Design and develop HVAC and plumbing systems for industrial and commercial...

  • Senior Innovation Engineer

    4 weeks ago

    Lawrence, Kansas, United States New Balance Athletics, Inc. Full time

    About the Role:New Balance Athletics, Inc. is seeking a Senior Innovation Engineer to join our Moonshot Innovation Group. As a key member of our team, you will be responsible for researching new technologies, materials, and design tools to identify future innovation opportunities.You will work closely with global partners and new vendors to envision future...

  • Senior Power Systems Engineer

    4 weeks ago

    Lawrence, Kansas, United States Synergy Staffing Full time

    Senior Power Systems EngineerThe Senior Power Systems Engineer is a key member of our team, responsible for performing system studies on electrical distribution, generation, and transmission systems. This role requires strong technical expertise and excellent communication skills to direct other engineers on a project-by-project basis.Key...

  • Engineering CAD Design Specialist

    3 weeks ago

    Lawrence, Kansas, United States JEO Consulting Group Full time

    Job OverviewJEO Consulting Group is a leading multidisciplinary firm that values great work-life integration and a relaxed, supportive, and inclusive environment. We are seeking a detail-oriented and skilled Engineering CAD Design Technician to join our Water Resources Engineering Department.The successful candidate will be responsible for producing...

  • Senior Mechanical Engineer

    3 weeks ago

    Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full time

    Job Summary:As a Senior Mechanical Engineer at Fresenius Medical Care, you will lead the development of class II medical devices, overseeing all aspects of mechanical design and integration from concept to production launch. You will mentor junior engineers and support the implementation of best practices across the organization.Key Responsibilities:...

  • Senior Power Systems Engineer

    3 weeks ago

    Lawrence, Kansas, United States Synergy Staffing Full time

    The Senior Power Systems Engineer is responsible for performing system studies on electrical distribution, generation, and transmission systems. This role involves directing other engineers on a project-by-project basis and reporting to the Engineering Manager.Key Responsibilities:Perform short circuit calculations, overcurrent coordination, load flow, and...

  • Senior Project Engineer

    3 weeks ago

    Lawrence, Kansas, United States Lawrence KS Full time

    Job Summary:Bartlett & West is a leading engineering, architecture, technology, and professional services firm headquartered in Topeka, KS. As a completely employee-owned company, we prioritize service to our clients, communities, and each other. We are seeking a skilled Civil Engineering Project Manager to join our team.The successful candidate will design...

  • Senior Project Engineer

    4 weeks ago

    Lawrence, Kansas, United States Lawrence KS Full time

    Job Summary:This position will design civil engineering projects, focusing on transportation. The successful candidate will work closely with the Project Manager to identify and develop the scope of work, meet customer expectations, assist in pricing contracts, perform engineering services, oversee project quality, identify resources, and manage them...

  • Senior Project Engineer

    3 weeks ago

    Lawrence, Kansas, United States Lawrence KS Full time

    Job Summary:Bartlett & West is an engineering, architecture, technology, and professional services firm headquartered in the Midwest. As a completely employee-owned company, we prioritize service to our clients, communities, and each other. We focus on supporting our team members to make the greatest impact.Key Responsibilities:Develops plans and...

  • Transportation Engineer

    4 weeks ago

    Lawrence, Kansas, United States Jeo Consulting Group Full time

    Company OverviewJEO Consulting Group is a unique engineering firm that values a welcoming and inclusive culture. Our team members are our greatest strength, and we prioritize building relationships and providing opportunities for growth.We offer a relaxed and supportive work environment that encourages communication and collaboration. If you value work-life...

  • Senior Bridge/Structural Engineer

    3 weeks ago

    Lawrence, Kansas, United States JEO Consulting Group Full time

    Job OverviewJEO Consulting Group is a leading multidisciplinary firm that prioritizes building people and providing opportunities. We have a welcoming, fun, and laid-back culture that encourages communication and collaboration.Our Transportation Department provides expertise and services including traffic engineering, transportation planning, roadway design,...

  • Systems Engineer II

    4 weeks ago

    Lawrence, Kansas, United States Fresenius Medical Care Holdings, Inc. Full time

    Purpose and Scope: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...

  • Systems Engineer II

    4 weeks ago

    Lawrence, Kansas, United States Fresenius Medical Care Holdings, Inc. Full time

    Job 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...

  • Product Development Engineer

    3 weeks ago

    Lawrence, Kansas, United States Horizon Systems Full time

    Job OverviewHorizon Systems is seeking a highly motivated and detail-oriented Product Development Engineer to join our team.This internship provides an opportunity to gain hands-on experience in product development, working closely with our engineering and fabrication departments.Responsibilities include:Creating and updating standard drawings, routings, and...

  • Road Design Manager

    4 weeks ago

    Lawrence, Kansas, United States State of Kansas Full time

    Job Summary:The Road Design Leader is a key position in the State of Kansas, responsible for directing a team of engineers and technicians in developing or coordinating the development of plans for transportation system improvement.Responsibilities:Administers policies and procedures to be followed by squad personnel and consulting engineering firms in the...

Senior Design Assurance Engineer

2 months ago

Lawrence, Kansas, United States FRESENIUS MEDICAL CENTER Full time
Job Title: Sr. Design Assurance Engineer

This is a remote or hybrid position at Fresenius Medical Center.

Purpose and Scope

As a Sr. Design Assurance Engineer, you will participate in New Product Development (NPD) and design changes, Design History File (DHF) and review meetings, and fully understand the design control process and Quality Engineering.

You will utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO 13485 and ISO 14971 requirements.

Key Responsibilities
  • Responsible for assuring projects meet customer expectations and regulatory requirements.
  • Act as a subject matter expert on design control process and Quality Engineering, including Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV).
  • Provide guidance to engineering staff and other personnel, and ensure that design control requirements are being met in an effective manner to achieve quality by design.
  • Review and approve design control related Change Notices (CNs) within the documentation system as applicable.
  • Assist in the development and maintenance of company procedures for design control, change management, risk management, process validation, and related areas of the quality management system.
  • Work independently on high-visibility new product development projects, including projects involving multiple technologies and design sites.
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
Requirements
  • Bachelor's Degree in a related engineering or scientific discipline required; Advanced Degree desirable.
  • 8 years' related experience; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent directly related work experience.
  • Familiar with critical elements of the design history file, including risk management, design verification and validation tests, and ensuring compliance of these elements to procedural requirements.
  • Ability to multi-task and operate within a fast-paced environment.
  • Strong organizational and presentation skills required.
  • Excellent oral, written, analytical, computer, and interpersonal skills.