Medical Device Designer: Engineering Career Path

Insulin pumps, pacemakers, and MRI machines are just a few examples of advanced medical devices that have saved countless lives. Whether they make essential daily drugs easier to administer or help detect diseases before they spread, medical devices serve a variety of purposes in modern medicine. 

Just as important as the devices themselves are the people who create them. But what does medical device design entail, and what educational background and skills are needed to pursue a career as a medical device designer? 

What Is Medical Device Design?

Medical device design is the process of creating and refining plans for manufacturing medical devices. These devices are used by nearly all types of healthcare providers and patients and in many settings. 

To be classified as a medical device, a product must meet the standards of the U.S. Food and Drug Administration (FDA). For instance, the instrument, machine, implant, or other object must be intended to diagnose, treat, heal, or prevent a disease, condition, or illness.

Generally, medical devices fall under one of three categories, as designated by the FDA: 

• Class I devices: low-risk products such as tongue depressors and analog wheelchairs
• Class II devices: moderate-risk products such as electric wheelchairs and CT scanners
• Class III devices: high-risk products such as pacemakers and cardiovascular stents

What Does a Medical Device Designer Do?

Medical device designers must have a deep understanding of clinical processes and procedures that allows them to design devices with healthcare providers’ and patients’ needs in mind. Anyone designing medical devices in the United States must be familiar with all regulatory requirements for medical devices as well. They also must be creative, innovative, and interested in problem-solving. 

The medical device design process can vary depending on the product. However, medical device designers typically follow three stages of development when creating a new device:

Conceptualization 

Medical device designers first identify a problem or unmet need. How can providers and patients benefit from a device that has not yet been created? What design elements and features would solve their biggest challenges? What products could offer both technical and market viability? Answering these questions helps medical device designers develop ideas for conceptually feasible devices. 

Design

In this stage, designers collaborate with medical professionals, engineers, clients, and other stakeholders to ensure their device idea will address healthcare providers’ and patients’ real-world needs. They then produce models and blueprints for their device idea. Working with engineering project managers can help medical device designers keep this process on track.

Development

The last stage in medical device design requires working with engineers to create a prototype of the device. The prototype must be tested at every step, and engineers must ensure they are following quality control best practices. Changes the engineers make need to go back to the designers, who refine and iterate the design. This process continues, with engineers and designers focusing on verification and validation at every step, until the device is ready for approval by regulatory agencies. 
 

Steps to Become a Medical Device Designer

Medical device designers rely on a variety of skills and competencies, including industrial and product design skills, computer-aided design (CAD) and software skills, and regulatory compliance knowledge. Designers can gain these skills through experience and the right education.

Education

Most medical device design positions require at least a bachelor’s degree in biomedical engineering, mechanical engineering, electrical engineering, or a related field. While entry-level positions don’t typically require an advanced degree, earning a relevant master’s degree, such as a Master of Science in Medical Device Engineering, can help professionals stand out to employers for senior and leadership positions.

Certification

While a certification isn’t usually required for the role, holding a specialized credential can help medical device designers advance in their careers. The following credentials are widely respected in the field:

Certified Medical Device Auditor

Candidates for the certified medical device auditor (CDMA) credential must have five years of experience and education in the field, including having at least one year of experience in a decision-making position, and pass an examination.

Quality System Regulation Certified Compliance Professional

Medical device designers interested in expanding their knowledge of quality control and regulations can pursue the quality system regulation certified compliance professional (QSRCP) credential. Holding this certification demonstrates expertise in how medical device prototypes are submitted and approved, and how to properly understand and control risks throughout the process.

Certified Medical Device Compliance Professional

Holding the certified medical device compliance professional (CMDCP) credential demonstrates knowledge of the steps of the compliance process, including the quality assurance, product design, and clinical trial steps. This certification can help medical device designers showcase their expertise in the FDA’s regulation and approval processes.
 

Salary and Job Outlook for Medical Device Designers

The median pay for bioengineers and biomedical engineers, including medical device designers, was $106,950 in 2024, according to the U.S. Bureau of Labor Statistics. Positions for bioengineers and biomedical engineers are expected to increase by 5% between 2024 and 2034, and an average of about 1,300 openings are projected for these professionals each year.
 

Become a Medical Device Designer

Pursuing a career as a medical device designer offers professionals many opportunities to solve complex problems and improve people’s lives. It’s also an ideal way to combine a love of design with a passion for medicine and healing. 

The online Master of Science in Medical Device Engineering program at the Tseng College at California State University, Northridge, helps students learn comprehensive skills and gain real-world experience in areas such as medical device design, biomaterials selection, production, and compliance. The two-year program teaches students how to apply engineering expertise to healthcare challenges and develop medical devices that can make a difference in people’s lives. 

Find out how CSUN’s master’s in medical device engineering can help you advance toward a rewarding career.