Food and Drug Administration

Biomedical Engineer

Food and Drug Administration

Remote
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you passionate about using your engineering skills to improve public health and safety? The Food and Drug Administration (FDA) is seeking a highly qualified Biomedical Engineer to join our team. As a Biomedical Engineer at the FDA, you will play a crucial role in ensuring the safety and effectiveness of medical devices and equipment used by millions of people. We are looking for individuals with a strong background in biomedical engineering and a commitment to upholding the highest standards of quality and safety. If you are ready to make a meaningful impact on the healthcare industry, we encourage you to apply for this exciting opportunity.

  1. Conduct thorough research and analysis on medical devices and equipment to ensure their safety and effectiveness for public use.
  2. Collaborate with cross-functional teams to review and evaluate technical data, design specifications, and risk management plans for medical devices and equipment.
  3. Utilize knowledge of biomedical engineering principles and regulations to develop and implement rigorous testing protocols and procedures.
  4. Identify and address any potential design flaws or safety concerns in medical devices and equipment.
  5. Stay up-to-date on industry advancements and regulatory changes to inform decision-making and ensure compliance with FDA standards.
  6. Provide technical support and guidance to other team members and external stakeholders on biomedical engineering matters.
  7. Communicate findings and recommendations to senior management and regulatory authorities in a clear and concise manner.
  8. Participate in the development and revision of policies and procedures related to medical device evaluation and regulation.
  9. Conduct on-site inspections and audits of manufacturers to assess their compliance with FDA regulations and standards.
  10. Maintain accurate and detailed records of testing procedures, results, and any corrective actions taken.
  11. Identify and report any potential risks or non-compliance issues to ensure the safety and effectiveness of medical devices and equipment on the market.
  12. Continuously evaluate and improve processes and procedures to streamline and enhance the effectiveness of the FDA's biomedical engineering operations.
  13. Uphold the highest standards of quality and safety in all aspects of work and promote a culture of excellence within the FDA.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • A Bachelor's Degree In Biomedical Engineering Or A Related Field: This Is The Minimum Educational Requirement For A Biomedical Engineer Position At The Fda. A Strong Foundation In Engineering Principles And Biomedical Sciences Is Necessary For This Role.

  • Knowledge Of Fda Regulations And Guidelines: As A Biomedical Engineer At The Fda, It Is Crucial To Have A Thorough Understanding Of The Regulatory Landscape And Compliance Requirements For Medical Devices, Drugs, And Other Healthcare Products.

  • Experience In Product Development And Testing: Candidates Should Have Experience In Developing And Testing Medical Devices Or Pharmaceutical Products, As This Is A Key Responsibility Of A Biomedical Engineer At The Fda.

  • Excellent Analytical And Problem-Solving Skills: Biomedical Engineers At The Fda Are Responsible For Evaluating Complex Technical Data And Making Critical Decisions That Impact Public Health. Strong Analytical And Problem-Solving Skills Are Essential For This Role.

  • Communication And Teamwork Abilities: Collaboration And Effective Communication Are Essential For A Biomedical Engineer At The Fda, As They Work Closely With Other Engineers, Scientists, And Regulatory Professionals To Ensure The Safety And Efficacy Of Healthcare Products.

Required Skills
  • Product Development

  • Quality Assurance

  • Project Management

  • Data Analysis

  • Communication

  • Clinical Research

  • Problem Solving

  • Technical Writing

  • Risk assessment

  • Regulatory compliance

  • team

  • Medical Device Testing

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Empathy

  • Decision-making

Compensation

According to JobzMall, the average salary range for a Biomedical Engineer is between $56,000 and $133,000 per year. This range can vary depending on factors such as experience, education, and location. Additionally, salaries can also be affected by the specific industry in which the engineer works, such as medical device manufacturing or research and development.

Additional Information
Food and Drug Administration is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedDecember 11th, 2024
Apply BeforeJune 9th, 2026
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About Food and Drug Administration

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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