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Fda Biomedical Engineering Jobs (NOW HIRING)

Varsity Tutors

Biomedical Engineering Tutor

Orlando, FL · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

Provo, UT · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

FL · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

TX · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

Irving, TX · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

Norwalk, CT · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

Lynn, MA · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

Varsity Tutors

Biomedical Engineering Tutor

PA · Remote

$40/hr

Familiar with biomedical engineering curricula and common challenges such as integrating biology with engineering mathematics, understanding physiological systems, and navigating FDA regulatory ...

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Fda Biomedical Engineering information

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$41K

$94.8K

$140K

How much do fda biomedical engineering jobs pay per year?

As of Jun 5, 2026, the average yearly pay for fda biomedical engineering in the United States is $94,807.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $116,000.00 per year, depending on experience, location, and employer.

What is the difference between Fda Biomedical Engineering vs Biomedical Equipment Technician?

AspectFda Biomedical EngineeringBiomedical Equipment Technician
Required CredentialsBachelor's degree in biomedical engineering or related field; certifications like Certified Biomedical Equipment Technician (CBET) are commonAssociate's degree or certification in biomedical technology; CBET certification often preferred
Work EnvironmentDesign, develop, and test medical devices; collaborate with regulatory agencies like the FDAMaintain, repair, and calibrate medical equipment in hospitals or clinics
Employer & Industry UsageMedical device companies, research institutions, regulatory agenciesHospitals, clinics, biomedical service companies

Fda Biomedical Engineering professionals focus on designing and testing medical devices, ensuring regulatory compliance, and working closely with agencies like the FDA. In contrast, Biomedical Equipment Technicians primarily maintain and repair medical equipment in clinical settings. Both roles require technical knowledge but differ in scope and responsibilities.

What are some unique challenges faced by FDA Biomedical Engineers in regulatory review processes?

FDA Biomedical Engineers often encounter the challenge of staying current with rapidly evolving medical technologies while ensuring that new devices meet stringent safety and efficacy standards. They must balance scientific innovation with regulatory compliance, often collaborating closely with multidisciplinary teams including scientists, clinicians, and manufacturers. Additionally, interpreting complex technical data under tight deadlines and communicating findings clearly to both technical and non-technical stakeholders are key aspects of the role. This environment requires strong analytical skills, adaptability, and effective teamwork to support public health.

What are the key skills and qualifications needed to thrive as an FDA Biomedical Engineer, and why are they important?

To thrive as an FDA Biomedical Engineer, you need a solid background in biomedical engineering principles, regulatory science, and a relevant engineering degree. Familiarity with FDA regulations, quality management systems, and tools like CAD software and data analysis platforms is crucial. Excellent analytical thinking, attention to detail, and effective communication skills help in evaluating medical devices and collaborating with stakeholders. These skills ensure the safety, efficacy, and regulatory compliance of medical products reviewed by the FDA.

What is an FDA biomedical engineer?

An FDA biomedical engineer is a professional who applies engineering principles to evaluate, regulate, and oversee medical devices and technologies for safety and effectiveness. They work within the U.S. Food and Drug Administration to review product submissions, conduct research, and help develop policies and standards that ensure medical devices meet regulatory requirements. These engineers play a crucial role in protecting public health by ensuring that devices used in healthcare are safe and perform as intended.

Biomedical Engineer

Tunnell Government Services

Bethesda, MD

Other

Posted 8 days ago

Job description

Biomedical Engineer SME Position Description

The successful candidate will be a Biomedical Engineer, with broad experience in aspects of the discipline that are relevant to the medical device domain, e.g., design, development, refinement, etc. They will provide scientific, technical, product development, product validation, and sustaining engineering advice as part of regulatory review of medical devices, with specific attention to premarket submissions. Such submissions include Premarket Notification (510(k)), Premarket Approval Application (PMA), etc.

The candidate should  have demonstrated at the interface of advanced engineering and clinical medicine.  Expertise in areas of research and development, quality and regulatory affairs, manufacturing and production, and clinical evaluation and field support should be evident. Additional specialization in relevant areas, such as biomaterials, biomechanics, bioinstrumentation, is desired. 

The candidate should be familiar with applicable industry standards and regulatory requirements, such as, but not limited to, FDA Guidances (Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices), US regulatory standards (21 CFR Part 820 -- Quality System Regulation), and ANSI standards (ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices).

Qualifications

  • The candidate must possess a bachelor's degree (BS) in biomedical engineering.
  • An advanced degree (MS, PhD) in a related/applicable field is strongly preferred.
  • 10 years of experience is required
  • Experience with directly supporting FDA 510(k) and related regulatory submissions is preferred
  • Exceptionally strong written and verbal communication skills
  • Ability to communicate well with others using excellent written and verbal communication skills.
  • Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
  • Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.)

Responsibilities

  • The primary focus of the role is to support analyses of medical devices relative to regulatory and technical aspects of biomedical engineering.
  • Provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, IDE, Combination Devices, and De Novo marketing applications, Pre-submissions)
  • Participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders
  • Develop written reviews and correspondence
  • Write detailed documents and reports

Must be a US Citizen or Full Green Card holder.

Job Type:  Full Time Employee

Schedule:  Monday through Friday (No Holidays)

Location:  This position is 100% telework. 

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