The Graduate Certificate in Biomedical Device Development addresses the clinical evaluation, regulatory, and commercial aspects of medical device development.  It has been widely recognized by our industrial advisors, recent graduates, and industry adjuncts that having knowledge in this area is paramount to building a successful career as a biomedical engineer.  The Department of Biomedical Engineering currently offers several online courses that address this need as part of our MS program in Biomedical Engineering. Enrollment in these courses and feedback by students has been overwhelmingly positive.

Who would be suited to take this program? 

Working professionals in the biomedical engineering and related industries in the New Jersey area. Areas include manufacturing, universities, hospitals, research facilities of companies and educational and medical institutions, and government regulatory agencies.

What will I learn?

• Cellular and Molecular Tissue Engineering - This course focuses on molecular, cellular and tissue level interactions that are an important component of all tissue engineering strategies. Topics include how a cell moves, reacts and maintains viability and function based on its surroundings. We will discuss how to engineer our materials, tissue grafts and implants to integrate with the body. We will also learn about bodily reactions and the biocompatibility of tissue engineered devices such as immunoreactivity and blood coagulation.

• Systems Management for Medical Devices - This course focuses on Project Management techniques and methods applied to medical devices and the integration of medical device Design Controls from 21 CFR820.30. General knowledge from the field of Project Management will be conveyed from the perspective of engineering or science personnel in the industrial medical field, particularly with regard to FDA Quality System Regulations (QSR), ISO 13485 guidelines, and Good Clinical Practices (GCP's) for running clinical trials. Students will also take part in practical problem solving simulations based on real-world examples of medical device project anomalies. The combination of specialized project management knowledge for a heavily regulated area and realistic classroom simulation will provide a basis for those interested in commercial medical device development.

• Medical Device Development - This course focuses on medical device development from a realistic industrial and academic perspective. The processes used in corporations and academic laboratories to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. Material will be presented as an aide to students who wish to decide on careers in either industry or academia.

• No Code Data Exploration - This course focuses on how to work with data and find useful insights without needing to write code. Students explore no-code tools that allow users to clean, analyze, and visualize data using drag-and-drop interfaces and AI-powered features. The course covers both traditional spreadsheet data and complex formats, such as text documents and images. Students learn to identify trends, create predictions, and build recommendation systems using visual tools. A major emphasis is placed on transforming analysis results into clear and concise presentations for various audiences. Through real-world projects, students build a portfolio showcasing comprehensive analysis workflows across various business scenarios. Students completing this course will feel confident tackling data analysis projects using visual tools, making them valuable contributors at data-driven organizations.

• Management Science - This course focuses on linear programming, transportation and assignment problems, Markov chains for decision-making, queueing systems, and deterministic and stochastic inventory models. These tools help students optimize resources, production, and supply chains. The course also develops skills in planning, coordinating, and executing complex projects. Students learn to meet regulatory and quality standards, which is critical for bringing safe and effective medical devices from concept to market.

• Project Management - This course focuses on concepts of project management and techniques for planning and controlling of resources to accomplish specific project goals. While the focus is on technically-oriented projects, the principles discussed are applicable to the management of any project. Topics include time, cost considerations, cash flow forecasting, financial and performance control, documentation.

Why study Biomedical Device Development at NJIT?

The U.S. medical device market, valued at $180 billion in 2024, is projected to grow 6.2% annually through 2034, driving strong demand for jobs in development, manufacturing, and regulatory roles.

NJIT’s Graduate Certificate in Biomedical Device Development is distinctive in its holistic approach, integrating technical engineering principles, regulatory knowledge (FDA QSR, ISO 13485, GCP), project management, clinical evaluation, and commercial considerations across the full device lifecycle. The program is designed for working professionals seeking applied skills that prepare them for a range of industry roles, while also offering the flexibility to apply coursework toward an MS in Biomedical Engineering.

The current job titles most interested in this field would be:

Engineering / Technical Roles:

• Medical Device Engineer

• Product Development Engineer

• R&D Project Engineer

• Verification & Validation Engineer

• Hardware/Electronics Engineer (Medical Devices)

• Process/Production Engineer

• Systems Engineer

Quality / Compliance Roles:

• Quality Assurance (QA) Engineer

• Quality Control (QC) Engineer

• Compliance Engineer

• Medical Device Reporting (MDR) Specialist

Project / Program Management Roles:

• Project Engineer

• Project Manager (Medical Devices)

Other Industry Roles:

• Regulatory Affairs Specialist

• Clinical/Regulatory Project Coordinator

• Medical Device Sales Specialist

​​In addition, holders of this graduate certificate may find employment in the following industries: Health Care, Health Sciences, Biomedical Engineering, medical device industry, pharmaceutical industry, and other life science related industries.

​​Prerequisites

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.   

Related Degree Programs

The graduate certificate program in Biomedical Device Development can be applied towards an MS in Biomedical Engineering. Students with an undergraduate degree in Biomedical Engineering may transfer all certificate courses with a minimum grade of B to the MS program. Students from other disciplines may apply up to two certificate courses toward the MS in Biomedical Engineering. 

What are the Required Courses?

The Graduate Certificate in Biomedical Device Development can be completed by taking four courses (12 credits). The requirements must be satisfied as indicated in the following Course List.

Course List

Code	Title	Credits
Core Courses
Select at least three of the following:
BME 652	Cellular and Molecular Tissue Engineering
BME 682	System Mgmt for Medical Device
BME 684	Medical Device Development
BME 698	Selected Topics
Elective Courses
Select at most one of the following:
EM 602	Management Science
EM 636	Project Management