The medical device field is growing fast, and skilled professionals are needed to bring safe, effective innovations to market. NJIT’s Graduate Certificate in Biomedical Device Development prepares you to understand the clinical evaluation process, meet FDA approval requirements and contribute to medical device commercialization. This online program prepares professionals to advance their careers in medical technology at the intersection of engineering, healthcare and regulation. Apply today If you’re ready to begin your journey.
 

Why Choose NJIT for Your Biomedical Device Development Certificate

NJIT’s Department of Biomedical Engineering has a strong reputation for innovation, research and industry partnerships. Our faculty combine research excellence with real-world experience in biomedical product development, quality assurance in medical devices and healthcare technology innovation. By studying at NJIT, you’ll learn from experts and gain practical skills valued by employers across the medical device industry. You’ll also benefit from the university’s connection to New Jersey’s thriving life sciences sector.
 

Program Overview

• Total credits: 12 
• Average completion time: 2 semesters 
• Format: 100% online 
• Core Curriculum 
• How to Apply 
• Financial aid options*

*Tuition reimbursement may be available through your employer 

The Graduate Certificate in Biomedical Device Development provides focused training that blends science, engineering and regulatory knowledge. In just a few courses, you’ll gain specialized insight into:

• Regulatory affairs for medical devices
• Orthopedic device design and principles of biomaterials and biomechanics
• Best practices for quality assurance in medical devices
• Adapting to medical device industry trends

Credits earned in this certificate may be applied toward select NJIT master’s programs, offering a flexible, stackable pathway to further study.
 

Who Should Apply?

This program is ideal for:

• Working professionals in medical and educational institutions seeking regulatory and commercialization expertise
• Professionals in biomedical engineering aiming to move into regulatory or product development roles
• Healthcare professionals looking to contribute to medical technology safety, testing and approval
• Recent graduates pursuing careers in the medical device industry
   

What You’ll Learn

By completing this program, you will:

• Explore project management methods, FDA Quality System Regulations (QSR), ISO 13485 and Good Clinical Practices (GCPs). Students complete simulations based on real-world device challenges.
• Gain a broad overview of device creation in academic and corporate settings, covering regulatory, clinical, QA/QC, legal and marketing perspectives.
• Study processes from “design freeze” through clinical evaluation and product launch, with emphasis on quality systems, manufacturing and compliance.
• Learn about biomaterials and biomechanics for orthopedic devices, including fixation systems, tissue-engineered constructs and orthobiologics, along with regulatory approval considerations.
   

Career Outcomes

Graduates are prepared for careers in:

• Medical technology companies and startups
• Biomedical engineering research and development
• Regulatory affairs and compliance in the medical device sector
• Quality assurance and project management roles in life sciences

Job titles suited to this program include: 

• Medical Device Engineer
• R&D Project Engineer
• Quality Engineer or Assurance Analyst
• Medical Device Reporting Supervisor
• Project Engineer or Product Manager 
• Medical Device Sales

Recent NJIT graduates have been hired by leading companies such as Bristol Myers Squibb, Lumen Technologies and Northrop Grumman. If you’re ready to take the next step, apply today.
 

Admissions Requirements

This program accepts students for the Fall and Spring semesters. For helpful resources on how to apply for the online graduate certificate, refer to: 

• How to apply  
• Application checklist  
• Important dates and deadlines  
• Graduate program FAQs 
   

Why Biomedical Device Development Matters Today

The medical device industry is evolving rapidly, with smaller entities driving innovation and industry-wide mergers and acquisitions reshaping the market. Professionals with expertise in regulatory affairs, commercialization and design are in high demand.

Earning a graduate certificate in Biomedical Device Development positions you to play a vital role in advancing healthcare technology innovation, ensuring compliance with FDA approval requirements and meeting the growing global demand for safe, effective devices.
 

Frequently Asked Questions

• Do I need experience in biomedical engineering to apply?
  An undergraduate degree in engineering, with an undergraduate cumulative grade point average (GPA) of at least 3.0 on a 4.0 scale is required. Applicants with a science degree and relevant industrial experience may be considered for conditional admission. Applicants with a GPA below 3.0 but at least 2.8, may also be conditionally admitted to the program.
• How does this certificate support my career goals?
  Adding a graduate certificate in Biomedical Device Development shows employers you have targeted skills and up-to-date knowledge. It sets you up for roles in product development, testing, quality control and regulatory affairs.
• Can I apply credits toward a master’s degree?
  Yes. This certificate is stackable and can be applied toward select NJIT online master’s programs.
• How long does it take to complete?
  Most students finish in under one year, depending on their course load.
   

Get Started

Next Steps

• Apply Now – Begin your application today
• Request More Information  – Connect with an admissions advisor
• Explore Tuition Support – See if you qualify for tuition reimbursement or financial aid