Biomedical Engineer jobs in the United States

Biomedical Engineer applies engineering and scientific principles and methodologies to design and develop medical technologies and devices to support and enhance patient care and improve healthcare outcomes. Conducts research and testing to address specific medical conditions, improve the performance of existing devices, and develop new products. Being a Biomedical Engineer collaborates with medical professionals to gather information for product specifications. Ensures that designs and devices meet regulatory, safety, and quality requirements and standards, such as the FDA regulations and ISO standards. Additionally, Biomedical Engineer utilizes or develops software to perform testing or integrate with devices. Requires a bachelor's degree in biomedical engineering or a related engineering or science discipline. Typically reports to a manager. The Biomedical Engineer work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Biomedical Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Systems Engineer
  • Centerline Biomedical
  • Cleveland, OH FULL_TIME
  • Position Summary:

    The Systems Engineer is an Exempt/Full-Time position that works alongside the development team to ensure product specifications are achieved and in compliance with medical regulatory practices and company procedures. The role assists in system risk analysis, as well as identification, prioritization, and documentation of customer needs and requirements. The Systems Engineer develops system and sub-system interface requirements that assure the completed system meets required functionality. Together with the development team, the Systems Engineer is responsible for investigation, evaluation, and selection of the best system structure and documentation. 


    Responsibilities/Duties:

    ● Responsible for overall system engineering / testing for a complex electromagnetic surgical navigation product platform.

    ● Develops/maintains system architecture and interface requirements for the products, based on technology and platform strategies.

    ● Defines subassembly interfaces and subassembly requirements to both internal and outsourced design teams.

    ● Implements and tests the product platform to ensure high quality, robust behavior and safety in accordance with medical device regulatory standards and customer requirements. 

    ● Responsible for daily system engineering activities including leading issue resolution and communication across teams in order to deliver results on-time and on-budget.

    ● Develops/maintains the risk management file in accordance with ISO 14971 and ensures product safety in accordance with IEC 60601-1 and its appropriate subparts.

    ● Works with other team members and functions to execute design reviews of complex Medical Devices.

    ● Drives structural design documentation and plans by applying engineering best practices. 

    ● Conducts impact analysis for design changes and implements necessary actions including estimates of impact to time, budget, and scope.

    ● Effectively coordinates test activities throughout the project to drive efficiency in V&V in collaboration with the regulatory resource to ensure a complete and effective 510(k) submission.

    ● Understands and follows quality and product development processes.

    ● Incorporates business, market, industry, and competitive knowledge into technical solutions.

    ● Determines required tasks and completes on time with minimal supervision.

    ● Identifies and communicates potential risks with appropriate mitigations.

    ● Synthesizes complex information gathered from a variety of sources and disseminates to others.

    ● Additional duties as assigned. 


    Minimum Qualifications, Education, and Experience Required

    Education and Experience:

    ● Bachelor’s degree with 3 years of medical device development experience is highly desirable

    ● Involvement with medical device regulatory standards such as IEC 60601, IEC 62304, ISO 14971 and ISO 13485 including experience with system risk/hazard analysis

    ● Experience with FDA 510(k) product/testing requirements

    ● Excellent IT/computer skills and a willingness to learn new tools as they become relevant

    ● Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision

    ● Ability to work efficiently on multiple tasks with deadlines

    ● Ability to work in a diverse team with members of varying education and experience levels

    ● Creative/innovative, able to rapidly problem-solve and work well given typical project schedules

    ● Superb organizational and multitasking skills as well as strong written and verbal communication skills

    ● Familiarity with ISO and IEC standards pertaining to medical devices


    Abilities:

    ● Proficiency with functional analysis and cascading down from user level to subsystem/ component level of customer requirements

    ● Experience working in Quality or Regulatory capacities in the medical device industry

    ● Skilled in developing test plans and validation protocols in a regulated environment 

    ● Capability of using automated software testing tools

    ● Familiarity with numerical analysis and methods

    ● Ability to work effectively in a multidisciplinary team while maintaining independence from technical development

    ● Strong analytical skills and willingness to develop understanding of relevant concepts in medicine and mechanical, electrical, and materials engineering

    ● Demonstrable experience in performing risk assessment, software validation and testing


    Work Conditions:

    Work is performed primarily in a standard office environment.  Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).  Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).



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    Centerline Biomedical is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions, and perspectives will build a strong foundation for success. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Centerline Biomedical will be based on merit, qualifications, and abilities. Centerline Biomedical does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.

  • 1 Day Ago

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Manufacturing Engineer II
  • Nova Biomedical
  • Billerica, MA FULL_TIME
  • Nova Biomedical is hiring a Manufacturing Engineer II in our Enterprise Rd, Billerica, MA facility who will be an essential member of the Manufacturing Engineering team. You will be responsible for id...
  • 9 Days Ago

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Quality Engineer I
  • Nova Biomedical
  • Waltham, MA FULL_TIME
  • Nova Biomedical is hiring a Quality Engineer I on-site (hybrid) in our Waltham, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). R...
  • 10 Days Ago

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Quality Engineer - Experienced
  • Gauthier Biomedical
  • Grafton, WI FULL_TIME
  • Summary: Ensures the verification, validation, manufacturing and testing of products meets customer expectations, industry standards, quality and regulatory requirements; performs investigations and t...
  • 2 Months Ago

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Packaging Engineer
  • Nova Biomedical Corporation
  • Billerica, MA FULL_TIME
  • Nova Biomedical Is hiring a Packaging Engineer to work on-site in our Enterprise Rd, Billerica, MA facility. This position will travel between all Billerica, MA and Waltham, MA facilities. The positio...
  • 3 Days Ago

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Quality Engineer
  • A&M Biomedical Inc.
  • Laguna Hills, CA FULL_TIME
  • The Quality Engineer is responsible for ensuring the overall quality of the production processes A&M Biomedical provides it’s customers. The QE is tasked with creating documentation, devising quality ...
  • 6 Days Ago

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Supervisory Biomedical Engineer
  • Veterans Affairs, Veterans Health Administration
  • Martinsburg, WV
  • Summary As the Supervisory Biomedical Engineer for the VA Medical Center at Martinsburg WV, the incumbent provides profe...
  • 6/11/2024 12:00:00 AM

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Cardiovascular (Echo) Sonographer 2
  • Inova Health
  • Lorton, VA
  • Inova HealthPlex - Lorton has an immediate need for a Cardiovascular (Echo) Sonographer 2. The Cardiovascular (Echo) Son...
  • 6/11/2024 12:00:00 AM

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Remote- Biomedical Engineer
  • Medasource
  • Washington, DC
  • Position: Biomedical Engineer Location: 100% Remote Duration: 18 month contract Job Summary – Biomedical Engineer The po...
  • 6/10/2024 12:00:00 AM

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Scientific Advisor - Biomedical Engineering (ARPA-H)
  • Ripple Effect
  • Washington, DC
  • Are you passionate about advancing health outcomes for all? Do you enjoy supporting innovative solutions to diverse, hea...
  • 6/9/2024 12:00:00 AM

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Anesthesia Technician
  • HH MedStar Health Inc.
  • Washington, DC
  • General Summary of Position Provides patient care and technical support to anesthesiologist and certified registered nur...
  • 6/9/2024 12:00:00 AM

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Biomedical Engineering Specialist
  • Noblis Corporation
  • Washington, DC
  • This is for potential upcoming opportunities. We will review your resume and reach out when an opportunity is available....
  • 6/8/2024 12:00:00 AM

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Patent Examiner (Biomedical Engineer)
  • Patent and Trademark Office
  • Alexandria, VA
  • Summary Do you aspire to use your engineering or science background to serve on the cutting edge of innovation? Now you ...
  • 6/8/2024 12:00:00 AM

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Clinical Data Scientist
  • Burtch Works
  • Washington, DC
  • Responsibilities Prepare, oversee, and maintain project schedules. Develop safety data review plans (SDRPs) with clinica...
  • 6/8/2024 12:00:00 AM

Income Estimation for Biomedical Engineer jobs
$63,950 to $81,909

Career Path for Biomedical Engineer