Starting a Career in Medical Device Development

Medical device development is the process of creating a functional medical device, from the inspiration phase to the post-market surveillance phase. Medical devices are used in all aspects of patient care, improving peoples’ lives and lowering healthcare costs.¹

The thriving medical device industry is expected to reach $595 million in 2024, offering many job opportunities for new engineers.² The rapid advancements of artificial intelligence, combined with the growth in recent years of digital therapeutics and biometric wearable technology, make this an exciting time to start a career in this dynamic business.

This post offers considerations for starting a career in medical device development, including the necessary education and skills, as well as possible career paths.

Emerging Technologies in Medical Device Development

Driven by an increasing emphasis on patient-centered care, medical device technologies are making a positive impact on healthcare delivery by facilitating effective, efficient and personalized care. Devices that are programmed with artificial intelligence and machine learning capabilities, for example, can tailor medical care to a patient’s health history data. Not all patients respond the same way to medicines and treatments. Medical devices can provide personalized care by tracking a patient’s responses so each treatment plan can be adjusted as necessary.³

In robot-assisted noninvasive surgery, systems such as the da Vinci Surgical System and the ROSA Spine robotic surgical assistant provide a less-invasive alternative to traditional surgery. Doctors can use them to operate with greater precision and reduce the cost, recovery time and complications of surgery.³

Educational Pathways and Qualifications

The development of a medical device is a highly technical process that draws on knowledge of engineering, technology and science. A bachelor’s degree that demonstrates high-level skills in medical science and engineering, such as a biomedical engineering degree, is the minimum requirement most companies look for when hiring.⁴

However, a master's degree in biomedical engineering will open up even more doors to an upper-level career. With an advanced degree, you can pursue more research and supervisory opportunities.⁴ A professional license such as the Professional Licensed Engineer (PE) credential will also demonstrate your commitment to the field and give you a competitive advantage over other candidates.

In conjunction with your formal education, a medical engineering internship can also offer the opportunity to learn from seasoned professionals in a real-world setting. You’ll gain hands-on experience and make connections that will be valuable to your career and instrumental in your success.⁴

Essential Skills for Medical Device Developers

This multi-disciplinary and dynamic career path requires a broad range of skills, from the technical to the creative. You’ll need a firm grounding in engineering principles and methods in order to iterate through the designing, prototyping, testing and optimizing phases. You'll also need a deep understanding of medical science and tools and technologies such as Python, CAD and MATLAB.⁵

Beyond the technical basics, medical device developers also have to understand regulatory compliance, as medical devices are subject to many industry standards and laws. The process of developing new or improved medical devices also requires creativity and problem-solving skills, as well as strong teamwork, collaboration and communication and a commitment to lifelong learning.⁵

Career Possibilities

Medical device developers can work in various jobs in biomedical engineering. Some have targeted responsibilities, working on one aspect of a device or process, while others work in broader roles that include all phases of development. Career prospects in medical device design include the following:

Systems Engineer

Systems engineers design, develop and test systems related to medical devices to ensure they’re effective, efficient and compliant with all applicable regulations. They work with vendors, clients and suppliers, so they need good technical and communication abilities, including critical thinking and knowledge of risk management, data architecture and information security.⁶

Project Manager

Project managers are responsible for directing and overseeing all aspects of medical device development. They create plans that include budgets, timelines, staffing and client communication. Because they have to balance so many different priorities and responsibilities within a team of professionals, they need strong communication, time management and organizational proficiency.⁶

Product Development Engineer

Product development engineers design or improve medical devices by drawing on a strong understanding of industry trends, patient needs and technological design. They create, prototype and test devices to achieve an optimal user experience.⁶

Bioprocess Engineer

Bioprocess engineers contribute to developing medical devices through their understanding of how cells and other biological organisms function. Their expertise helps create medical devices that achieve optimal health results, such as efficient delivery of chemotherapy agents.⁷

Research Engineer

Research engineers collect and analyze data to help medical device stakeholders make informed decisions about product development. Their responsibilities include investigating, modeling, testing and verifying research that could impact a device’s performance in clinical trials and real-world settings. This role demands superior analytical, critical-thinking, technical and communication skills.⁶

Ethical Considerations in Device Development

As with all aspects of healthcare, medical devices hold the potential not only to improve patient health and outcomes, but also to exacerbate risks and pose new threats. Unfortunately, devices often have a lower standard of evidence than other medical therapies, which has led to the approval of some devices, such as metal-on-metal hips and vaginal mesh, that were later found to be harmful.⁸

The integration of software in medical devices, such as pacemakers and insulin pumps, also presents new challenges. These include frequent updates affecting device functionality, cybersecurity risks and ethical concerns about the misuse of collected physiological data.⁶ Similarly, increased customization, especially through technologies like 3D printing, has the potential to transform healthcare but poses challenges for obtaining rigorous evidence of safety and effectiveness. Customized devices may bypass traditional regulatory controls, raising new risks.⁸

Moving forward, the industry may need to develop a new approach based on reasoned assessment and defensible ethical decisions, especially in the face of advancing technologies such as generative AI and machine learning.⁸

Advance Your Medical Device Design Career

Case Western Reserve University’s online MS in Biomedical Engineering program will prepare you for leadership and success in the field of medical device development. Our faculty members regularly engage in cutting-edge research and bring their deep expertise and enthusiasm to their classes. Learn on your own schedule in this entirely online program. Expand your professional network and build the foundation you need to stand out from the crowd in a dynamic, growing industry.

To learn more, schedule a call with one of our admissions outreach advisors today.