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Medtech engineering development program.

Write your own success story, spark bold innovation, and become an expert at what truly interests and inspires you. Join us and strategically enhance your own skillset while contributing to medical device breakthroughs that have real-world impact on the lives of people across the world.

The Program Be part of a pioneering team connecting science and technology to reimagine the future of surgery, orthopedics, and interventional solutions. From robotic-assisted devices to using virtual reality to test new prototypes, Johnson & Johnson Medical Technology Companies are turning breakthrough ideas into cutting-edge products that can streamline procedures, reduce costs, and improve outcomes for both physicians and patients. This MTEDP is designed to prepare exceptional engineers for a career in medical devices and high-volume manufacturing. Gain real-world experience supporting a wide variety of sectors that can include Research & Development, Life Cycle Management, Supply Chain, Operations, and Manufacturing.

The Opportunity

Full-time program Our MedTech Engineering Development Program (EDP) is a two to three-year* Early-In-Career Rotational Program that offers exciting and unrivaled assignment experiences supporting a wide variety of highly specialized, cutting-edge sectors across the engineering organization, such as: Research and Development, Life Cycle Management, Supply Chain, Operations, and Manufacturing.

• You will have opportunities to participate and/or lead in rotational assignments encompassing entire project or a large portion of a major project. This may include resolving advanced materials, process, inspection/testing or procedural approaches to advance a medical device through the pipeline process into full R&D, and potentially into commercialization.
• Support of products' design development, manufacturing and commercialization, leveraging technical expertise to anticipate and proactively address challenges and risks.
• Increase the productivity of product's design, improve the quality of projects, improve communications through documentation, and to create a database for manufacturing.
• Engineer capabilities required to develop and deliver automated medical devices - including requisite instruments, advanced imaging, and user interface / experience.
• Pursue a number of internal developmental training programs as well as externally recognized qualifications.
• Opportunity to work in a fast-paced cross functional, technologically advanced corporate environment in a program focused on developing individual engineers capable of pursuing careers across medical device businesses and high-volume manutacturers.

Summer program (12 weeks, May-August)

• A 12-week engineering internship, blending training programs and rotational assignments experiencing what it takes to advance a medical device through the pipeline into full R&D and potentially into commercialization

Are You Ready to Make a Difference? By participating in the program, you'll gain cross-functional leadership and technical expertise in a supportive, collaborative environment that pairs you with other specialists and groups within Johnson & Johnson. While providing input to concept selection, product characterization, detailed design, and test development, you'll cultivate deep-seated subject matter expertise while honing your communication skills to influence key internal and external stakeholders.

Who We're Looking For

Innovative, collaborative problem solvers with unique perspectives : these are the people who thrive at J&J and in this program. Specifically, the program is designed for those who bring:

• Undergraduate & Graduate Engineering Degrees with graduation dates between 2022 - 2024
• Preferred Majors: Mechanical, Robotics, Electrical, Computer, Systems, Software, Chemistry, Materials Science, Biomedical and Computer Science
• Up to two years of professional full-time postgraduate work experience (excluding internships, co-ops and military)
• Strongly preferred skil/experience: Machine Learning, loT, Embedded Software, Deep Machine Learning, Prototyping, Robot Design, Systems Reliability, Firmware and hardware integration
• Minimum GPA of 3.3 strongly preferred

RESEARCH & DEVELOPMENT

• Market leading products in diagnostics, nutrition, and medical devices
• 100+ year history of innovation
• Ranked as top medical technology company on Dow Jones Sustainability Index
• Chance to develop life-changing technology

JOIN OUR TALENT COMMUNITY

Medical Device Engineering: An Overview

View all blog posts under Articles | View all blog posts under Bioengineering

What does the lowly walking cane have in common with sophisticated MRI machinery? They’re both medical devices, whose purpose is to resolve health care issues and improve an individual’s quality of life and well-being. The engineering that goes into developing medical devices is both innovative and practical, taking into account design, functionality, manufacturability, and safety.

Engineering students who are interested in moving into the medical arena should consider an advanced education  — particularly master’s degree programs in engineering that can provide a foundation in the design and manufacture of medical devices.

What Is Medical Device Engineering?

Medical device engineering focuses on the design and manufacture of devices used in medical care. These devices include mobility aids (walkers, wheelchairs), individual diagnostic devices (blood pressure cuffs, blood glucose monitors), large-scale diagnostic machinery (MRI, PET, and X-ray scanners), and innovative drug delivery systems (nicotine patches, microdevices).

Medical device engineers, also known as bioengineers or biomedical engineers , work in laboratories and health care facilities, and for private corporations and government agencies. About 16% of all bioengineers work in medical equipment and supplies manufacturing, according to the U.S. Bureau of Labor Statistics (BLS). Another 16% work in research and development departments of engineering and life sciences organizations.

Besides their primary job description of medical product design and development, medical device engineers are responsible for:

• Software: Engineers may be tasked with developing the software to operate medical devices and other innovations.
• Maintenance: Installation and repair of devices are also part of the role’s responsibilities.
• Training: Medical device engineers train medical staff on the use of their products, which may be highly complex and dangerous if deployed improperly.
• Research: Before beginning the design process, engineers must investigate how the proposed product will interact with the human body.
• Collaboration: Teamwork and collaboration are a significant part of an engineer’s day-to-day responsibilities. They work with other scientists, medical experts, and clinicians to design products according to specifications.
• Testing: Before deployment, products undergo rigorous testing to confirm safety and efficacy. Medical device engineers collect and analyze data and apply their findings to redesign and improve products.
• Communications: Engineers publish their work in white papers and journals, present their findings to stakeholders, and develop user manuals and other documentation.

The Skills of a Medical Device Engineer

Successful medical device engineers combine strong technical, analytical, and creative thinking skills with their knowledge of medicine and health care. They stay abreast of new findings in lab-created and organic materials, as well as scientific breakthroughs such as nanotechnology.

Medical device engineering professionals also must have excellent interpersonal and communications skills, as they work in a highly collaborative and multidisciplinary environment.

Top Hard Skills

Hard skills for any career comprise the specific technical knowledge required for the job. For medical device engineers, that encompasses the following requirements.

Materials Knowledge

Medical device engineers have training in the properties of materials, both organic and non-organic, whether those are steel, ceramic, glass, mesh, porous, nanotech, or have other features. These properties affect product design.

Advanced Math and Science

Math, materials science, mechanical engineering, biology, chemistry, and physics combine to make up the engineer’s tool kit. Engineers must be experienced in using advanced math, such as calculus, statistics, and data modeling. They must also understand engineering and mechanics and how they interact with the human body, from the cellular level up to the musculoskeletal structure.

Analytical Mindset

Engineering requires a data-driven mindset and scientific perspective. Engineers must be able to assess the physical features of a product, the materials used, and its design, as well as patient needs. They must thoroughly understand the product’s intended use and be willing to look at data objectively in analyzing a product’s effectiveness.

Critical Thinking

From the beginning of the design process to the end of the product life cycle, engineers must apply critical thinking skills. They have to be able to analyze the scope of a design, its purpose, price, and manufacturability, among other factors. They must base their decisions on data gathered in the scope of modeling and user testing. They must also use critical thinking to identify challenges and solutions.

Top Soft Skills

The best engineers don’t work in a vacuum. They regularly collaborate with other professionals, including researchers and clinicians. Developing certain soft skills is key to success in the medical device engineering field. These skills contribute to a professional work environment and a productive team, and they are often combined under the heading of interpersonal skills.

Written Communication

Engineers keep logs of their daily activities. They make presentations to decision makers, outside stakeholders, and the non-technical community (health care workers, public officials, etc.). They also write for publication, including marketing white papers, scientific journals, and product documentation.

Oral Communication

Possessing excellent oral communication skills may be one of the most important competencies for engineers. They must be able to communicate and listen clearly and thoughtfully. Engineers not only communicate with their team, they also report to managers, executives, clients, and other stakeholders.

Engineering is a creative field, and engineers are creative and innovative problem-solvers. They deal with complex systems, both mechanical and biological. Being inquisitive is key to creating innovative work as well as applying effective troubleshooting and problem-solving. Creativity is also key to being excited about and engaged with a project.

Medical device engineering is a collaborative process. Engineers must be able to work well with others, including engaging in brainstorming, problem-solving, project management, workflow coordination, and other tasks. Being a good team player is often essential to a successful career in the industry, as many employers prize collaboration.

Medical Device Engineer Salary

The BLS classifies the medical device engineering profession under the occupation bioengineers and biomedical engineers. In 2021, the median annual wage for engineers in the medical equipment and supplies manufacturing industry was $97,090, according to BLS data.

The BLS projects that demand for all bioengineering occupations will grow 6% between 2020 and 2030. Employment growth in this field will be partly driven by the country’s aging population. As people live longer and remain active, demand for the types of products medical device engineers create is expected to increase.

Build a Better Future in an Important Field

Medical device engineering offers a unique opportunity for creative engineers to make a difference in health care. If you’re excited about the idea of applying your engineering mindset to designing products that are lifesaving and life-changing, explore the online Master of Science in Engineering program at the University of California, Riverside. With concentrations including bioengineering and mechanical engineering, you can build a foundation in an exciting field.

Discover how the program can inspire you and prepare you for a rewarding career today.

Recommended Readings

5 Engineering Career Paths of the Future

Major Nanomaterials Use Cases in Medicine

The Most Promising Industries for Tomorrow’s Mechanical Engineers

123Test, Profession Medical Device Engineer

American Institute for Medical and Biological Engineering, “Why Biomedical Engineering?”

Biomedical Engineering Society, Medical Devices

Drug Delivery Business News, “8 Drug Delivery Innovations You Need to Know”

Indeed, “What Is a Medical Engineer? Definition and How to Become One”

Medical Design Briefs, “2021: Technology Trends and the Future of Medical Devices”

Proclinical, Manufacturing Engineer Jobs in Medical Device s

Thomas Publishing Company, “5 Vital Soft Skills for a Successful Career in Engineering”

U.S. Bureau of Labor Statistics, Bioengineers and Biomedical Engineers

Take charge of your future with an online Master of Science in Engineering

< -->R&D and Engineering Services

R&D and Engineering Services

World-Class R&D for Market-Defining Devices

Our Expertise

Wipro designs, develops, tests and validates products for medical device manufacturers. As the world’s largest 3rd party R&D service provider with 500+ customers, our 18,000+ consultants, experienced in working with key regulatory agencies in the US, Europe, Japan, China and Australia, do this by leveraging our expertise in software, mechanical and electronics engineering plus our partnerships with biomedical academics, hospitals, research institutions and industrial design houses. Clients using our R&D capabilities accelerate their time to market with services that include:

• New Product Development from concept to design, development and post product launch with a focus on innovation and regulatory alignment
• Product Sustenance services that add new features and addresses component/technology obsolescence for existing and end-of-lifecycle products
• Value Engineering that aims to enhance product features, builds interoperability, improves quality and reduces cost
• The service covers Clinical Diagnostics, Imaging Systems, Patient Monitoring, Medication Delivery Devices, Surgical Systems and Implantable Devices and has helped leading organizations launch multiple Class II/Class III devices

Our Success Stories

What we Think

Reducing the cognitive load in an OR by integration of devices

This position paper highlights a device integration platform proposed to bring together most parameters on a common platform so that their interplay may be better visualized and controlled to help reduction of cognitive load on the surgeon.

EMRGateway - Interoperability solution for medical devices

The need for “plug-and-play” interoperability – the ability to take a medical device out of its box and easily make it work with one’s other devices or applications– has attracted great attention from both healthcare providers and industry.

Medical devices: The Trend of M2M connectivity

Explore how M2M enables proactive service, allows for consumption-based business models and drives recurring revenue and improved customer experience

(De)sign Of Things to Come

Medical device companies weave new business models to provide value-added services

Wipro’s Accelerated Adaptive Manufacturing Framework for making Life-Saving Products

Rapid escalation of the current worldwide healthcare crisis is posing unprecedented challenges in terms of availability of life-saving medical devices.

Healthcare Intelligent Tracking

Integrated mobile-based offering

Wipro’s Quality and Regulatory (QARA) Services

OEMs need to remain competitive amidst regulatory changes in MedTech and Lifesciences.

Contact Wipro

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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.

• Retrieved on December 26, 2023, from medium.com/@drjonkiev/the-impact-of-medical-devices-on-healthcare-costs-a-comprehensive-analysis-9de82e4d996
• Retrieved on December 26, 2023, from alpha-sense.com/blog/trends/medical-device-trends-outlook/
• Retrieved on December 26, 2023, from luxoft.com/blog/technology-trends-and-the-future-of-medical-devices
• Retrieved on December 26, 2023, from indeed.com/career-advice/finding-a-job/how-to-become-medical-engineer
• Retrieved on December 26, 2023, from linkedin.com/advice/3/what-essential-skills-medical-device-product-e0xve
• Retrieved on December 26, 2023, from joinhandshake.com/blog/students/biomedical-engineering-jobs/
• Retrieved on December 26, 2023, from indeed.com/career-advice/finding-a-job/what-is-bioprocess-engineering
• Retrieved on December 26, 2023, from healthvoices.org.au/issues/november-2017/ethics-advanced-medical-devices-need-new-approach/

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Level-up your career opportunities with an accelerated master’s degree. Learn to develop medical devices and work with industry sponsors to solve real-world problems.

What if you could save someone’s life by inventing a groundbreaking medical device? Do you want to know how technology is harnessed to meet healthcare needs? During our accelerated Master of Science in Medical Device Engineering (MSMDE) program, students:

• Approach design problems by understanding the clinical setting and user needs.
• Apply industry practices to develop and manufacture viable medical devices.
• Work in teams with industry sponsors to solve real-world problems.

The program expands the career opportunities of our graduates, preparing them for engineering and related roles in research, development, and production of medical devices in specialties such as in-vitro diagnostics, assistive technology, or drug delivery.

If you would like to have a conversation about the MSMDE program, contact the program director, Anna Hickerson, [email protected] , to set up a meeting.

Interested in the MSMDE program?

Complete this form to receive more information, program quick facts, msmde program details.

At KGI, we focus on developing students’ skills in areas identified by industry partners. This helps students quickly expand their career opportunities. The MSMDE program is intentionally designed using information gained through research and interviews with alumni and employers. The program has an exceptional record for completion of the program and job placement in the medical device industry.

The curriculum  covers the essential areas of expertise to apply engineering skills to the specialized field of medical devices and provides authentic experiences with the industry. 

In support of their courses, students have access to the Medical and Assistive Device (MAD) Lab. Students use the room to work on class projects, team master’s projects, research activities, and as a place to study. The lab is equipped with modern prototyping equipment for electronics and mechanical work, such as a laser cutter, vacuum former, electronic testing equipment, and 3D printers. Students use this space for collaborating, designing, prototyping, and showcasing their work.

Industry Experience

The MSMDE program leverages the strong industry relationships of the Henry E. Riggs School of Applied Life Sciences to provide authentic experiences and networking opportunities for our students. These include:

• Visiting speakers
• Case-based coursework
• Industry sponsored projects
• Alumni network
• Advisory Board connections 

Culminating in a capstone experience— the Team Master’s Project —students work in teams with an industry sponsor and faculty support on a medical device project that integrates the curricular elements into a single experience.

MedTech is a vast and steadily growing industry with a need for qualified engineers. The MSMDE program helps develop the most requested skills, including:

• Product development
• Project management
• Quality management

Students will also develop sought-after professional skills through practice and mentorship, including:

• Communication
• Teamwork/collaboration
• Problem solving
• Organizational skills

Graduates of the program have started their post-graduate careers in positions including:

• Research and Development Engineer
• Product Development Engineer
• Process Engineer
• Manufacturing Engineer
• Field Application Scientist
• Medical Student

The knowledge from the degree combined with the experience in these positions opens opportunities to quickly advance.

The MSMDE program is designed for those with a passion for medical devices and diagnostics who want to:

• Apply engineering to healthcare problems
• Design devices to diagnose and treat medical needs
• Lead the development of the next generation of transformative medical devices
• Plan and manage the production of medical devices to improve worldwide healthcare

KGI’s Medical Device Engineering Program Now a One-Year Accelerated Master’s 

What if you could save someone’s life by inventing a groundbreaking medical device? Keck Graduate Institute (KGI)’s Master of Science in Medical Device Engineering (MSMDE) program, which started in 2019 […]

#155—Dr. Anna Hickerson on Medical Device Engineering

In this episode of the KGI podcast, Dr. Anna Hickerson, associate professor and program director for KGI’s Master of Science in Medical Device Engineering program, talks about her background, the […]

What Are Different Types of Engineering Master’s Degrees?

Do you have an insatiable curiosity? Do you enjoy learning by doing? Are you a creative problem-solver who loves working with others to find innovative solutions to complex challenges? Consider […]

KGI Celebrates 2021-2022 Accomplishments During Awards and Recognition Ceremonies

In celebration of KGI’s accomplishments during the 2021-2022 academic year, the Henry E. Riggs School of Applied Life Sciences (Riggs School) and School of Pharmacy and Health Sciences (SPHS) hosted […]

Program Faculty

Anna iwaniec hickerson, phd, angelika niemz, phd, ed arnheiter, phd, kiana aran, phd, james sterling, phd, day in the life of an msmde student.

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Medical device engineer

Description.

Medical device engineers design and develop medical-technical systems, installations, and equipment such as pacemakers, MRI scanners, and X-ray machines. They monitor the whole manufacturing process from concept design to product implementation. activities undertaken include, among others, designing product improvements, developing methods and techniques to evaluate design suitability, coordinating initial production, developing test procedures, and designing manufacturing diagrams.

Includes people working in hospitals. Includes people performing technical management and ensuring operational readiness of medical equipment in use.

Other titles

The following job titles also refer to medical device engineer:

engineer in biomedical systems engineer of medical devices biomedical systems developer engineer of medical instruments medical device developer biomedical systems engineer orthopaedic engineer audiology engineer medical technology engineer medical-technical equipment engineer medical-technical test engineer medical instrument engineer clinical engineer biomedical engineer medical-technical device engineer engineer of medical technology

Minimum qualifications

Bachelor’s degree is generally required to work as medical device engineer. However, this requirement may differ in some countries.

ISCO skill level

ISCO skill level is defined as a function of the complexity and range of tasks and duties to be performed in an occupation. It is measured on a scale from 1 to 4, with 1 the lowest level and 4 the highest, by considering:

• the nature of the work performed in an occupation in relation to the characteristic tasks and duties
• the level of formal education required for competent performance of the tasks and duties involved and
• the amount of informal on-the-job training and/or previous experience in a related occupation required for competent performance of these tasks and duties.

Medical device engineer is a Skill level 4 occupation.

Medical device engineer career path

Similar occupations.

These occupations, although different, require a lot of knowledge and skills similar to medical device engineer.

electromagnetic engineer electromechanical engineer automation engineer sensor engineer microsystem engineer

Long term prospects

These occupations require some skills and knowledge of medical device engineer. They also require other skills and knowledge, but at a higher ISCO skill level, meaning these occupations are accessible from a position of medical device engineer with a significant experience and/or extensive training.

Essential knowledge and skills

Essential knowledge.

This knowledge should be acquired through learning to fulfill the role of medical device engineer.

Biomedical science : The principles of the natural sciences applied to medicine. Medical sciences such as medical microbiology and clinical virology apply biology principles for medical knowledge and invention. Analytical methods in biomedical sciences : The various research, mathematical or analytical methods used in biomedical sciences. Engineering principles : The engineering elements like functionality, replicability, and costs in relation to the design and how they are applied in the completion of engineering projects. Design drawings : Understand design drawings detailing the design of products, tools, and engineering systems. Medical device test procedures : The methods of testing the quality, accuracy, and performance of medical devices and their materials and components before, during, and after the building of the systems. Mathematics : Mathematics is the study of topics such as quantity, structure, space, and change. It involves the identification of patterns and formulating new conjectures based on them. Mathematicians strive to prove the truth or falsity of these conjectures. There are many fields of mathematics, some of which are widely used for practical applications. Medical devices materials : The different materials used to create medical devices such as polymer materials, thermoplastic and thermosetting materials, metal alloys and leather. In the choice of materials, attention must be paid to medical regulations, cost, and biocompatibility. Technical drawings : Drawing software and the various symbols, perspectives, units of measurement, notation systems, visual styles and page layouts used in technical drawings. Physics : The natural science involving the study of matter, motion, energy, force and related notions. Engineering processes : The systematic approach to the development and maintenance of engineering systems. Quality standards : The national and international requirements, specifications and guidelines to ensure that products, services and processes are of good quality and fit for purpose. Biomedical techniques : The various methods and techniques used in biomedical laboratory such as molecular and biomedical techniques, imaging techniques, genetic engineering, electrophysiology techniques and in silico techniques. Biomedical engineering : The biomedical engineering processes used to create medical devices, prostheses and in treatments. Medical devices : Equipment and devices used in the diagnosis, prevention, and treatment of medical issues. Medical devices cover a wide range of products, ranging from syringes and protheses to MRI machinery and hearing aids. Medical device regulations : The set of national and international regulations with regards to the manufacture, safety, and distribution of medical devices. Mechanics : Theoretical and practical applications of the science studying the action of displacements and forces on physical bodies to the development of machinery and mechanical devices.

Essential skills and competences

These skills are necessary for the role of medical device engineer.

Model medical devices : Model and simulate medical devices using technical design software. Assess the viability of the product and examine the physical parameters to ensure a successful production process. Test medical devices : Make sure the medical devices fit the patient and test and evaluate them to ensure they work as intended. Make adjustments to ensure proper fit, function and comfort. Conduct literature research : Conduct a comprehensive and systematic research of information and publications on a specific topic. Present a comparative evaluative literature summary. Design medical devices : Design and develop medical devices, such as hearing aids and medical imaging equipment, according to specifications. Perform data analysis : Collect data and statistics to test and evaluate in order to generate assertions and pattern predictions, with the aim of discovering useful information in a decision-making process. Record test data : Record data which has been identified specifically during preceding tests in order to verify that outputs of the test produce specific results or to review the reaction of the subject under exceptional or unusual input. Conduct quality control analysis : Conduct inspections and tests of services, processes, or products to evaluate quality. Adjust engineering designs : Adjust designs of products or parts of products so that they meet requirements. Perform scientific research : Gain, correct or improve knowledge about phenomena by using scientific methods and techniques, based on empirical or measurable observations. Use technical drawing software : Create technical designs and technical drawings using specialised software. Develop medical device test procedures : Develop testing protocols to enable a variety of analyses of medical devices and components before, during, and after the building of the medical device. Read engineering drawings : Read the technical drawings of a product made by the engineer in order to suggest improvements, make models of the product or operate it. Design prototypes : Design prototypes of products or components of products by applying design and engineering principles. Report analysis results : Produce research documents or give presentations to report the results of a conducted research and analysis project, indicating the analysis procedures and methods which led to the results, as well as potential interpretations of the results. Operate scientific measuring equipment : Operate devices, machinery, and equipment designed for scientific measurement. Scientific equipment consists of specialised measuring instruments refined to facilitate the acquisition of data. Prepare production prototypes : Prepare early models or prototypes in order to test concepts and replicability possibilities. Create prototypes to assess for pre-production tests. Approve engineering design : Give consent to the finished engineering design to go over to the actual manufacturing and assembly of the product.

Optional knowledge and skills

Optional knowledge.

This knowledge is sometimes, but not always, required for the role of medical device engineer. However, mastering this knowledge allows you to have more opportunities for career development.

Electromechanics : The engineering processes that combine electrical and mechanical engineering in the application of electromechanics in devices that need electricity to create mechanical movement or devices that create electricity by mechanical movement. Electrical engineering : Understand electrical engineering, a field of engineering that deals with the study and application of electricity, electronics, and electromagnetism. Radiation physics in healthcare : The radiation physics related to conventional radiology, CT, MRI, ultrasound, diagnostic nuclear medicine and their principles such as areas of application, indications, contraindications, limitations and radiation hazards. Firmware : Firmware is a software program with a read-only memory (ROM) and a set of instructions that is permanently inscribed on a hardware device. Firmware is commonly used in electronic systems such as computers, mobile phones, and digital cameras. Medical imaging technology : Set of technologies used to creating visual representations of the body interior for the purposes of clinical analysis. Diagnostic radiology : Diagnostic radiology is a medical specialty mentioned in the EU Directive 2005/36/EC. Biotechnology : The technology that uses, modifies or harnesses biological systems, organisms and cellular components to develop new technologies and products for specific uses. Cae software : The software to perform computer-aided engineering (CAE) analysis tasks such as Finite Element Analysis and Computional Fluid Dynamics. Electronics : The functioning of electronic circuit boards, processors, chips, and computer hardware and software, including programming and applications. Apply this knowledge to ensure electronic equipment runs smoothly. Mechanical engineering : Discipline that applies principles of physics, engineering and materials science to design, analyse, manufacture and maintain mechanical systems. Human anatomy : The dynamic relationship of human structure and function and the muscosceletal, cardiovascular, respiratory, digestive, endocrine, urinary, reproductive, integumentary and nervous systems; normal and altered anatomy and physiology throughout the human lifespan. Control engineering : Subdiscipline of engineering that focuses on controlling the behaviour of systems through the use of sensors and actuators. Mechatronics : Multidisciplinary field of engineering that combines principles of electrical engineering, telecommunications engineering, control engineering, computer engineering, and mechanical engineering in the design of products and manufacturing processes. The combination of these areas of engineering allows for the design and development of “smart” devices and the achievement of an optimal balance between mechanical structure and control. Radiation protection : The measures and procedures used to protect people and the environment from the harmful effects of ionising radiation. Health informatics : Multidisciplinary field of computer science, information science, and social science that uses health information technology (HIT) to improve healthcare.

Optional skills and competences

These skills and competences are sometimes, but not always, required for the role of medical device engineer. However, mastering these skills and competences allows you to have more opportunities for career development.

Provide technical documentation : Prepare documentation for existing and upcoming products or services, describing their functionality and composition in such a way that it is understandable for a wide audience without technical background and compliant with defined requirements and standards. Keep documentation up to date. Wear cleanroom suit : Wear garments appropriate for environments that require a high level of cleanliness to control the level of contamination. Communicate with customers : Respond to and communicate with customers in the most efficient and appropriate manner to enable them to access the desired products or services, or any other help they may require. Design firmware : Design the appropriate firmware to a specific electronic system. Solder electronics : Operate and use soldering tools and soldering iron, which supply high temperatures to melt the solder and to join electronic components. Perform test run : Perform tests putting a system, machine, tool or other equipment through a series of actions under actual operating conditions in order to assess its reliability and suitability to realise its tasks, and adjust settings accordingly. Define manufacturing quality criteria : Define and describe the criteria by which data quality is measured for manufacturing purposes, such as international standards and manufacturing regulations. Manufacture medical devices : Put together medical devices according to company specifications and national and international regulations. Use specialised materials, tools, and machinery to assemble the medical devices. Apply molding, welding, or bonding techniques according to the type of medical device. Retain a high level of cleanliness throughout the manufacturing process. Create technical plans : Create detailed technical plans of machinery, equipment, tools and other products. Conduct training on biomedical equipment : Train clinicians and other personnel on the proper use of biomedical equipment. Coordinate engineering teams : Plan, coordinate and supervise engineering activities together with engineers and engineering technicians. Ensure clear and effective channels of communication across all departments. Make sure the team is aware of the standards and objectives of the research and development. Manipulate medical devices’ materials : Manipulate materials used in the manufacturing of medical devices such as metal alloys, stainless steel, composites or polymer glass. Use precision tools : Use electronic, mechanical, electric, or optical precision tools for precision work. Draft bill of materials : Set up a list of materials, components, and assemblies as well as the quantities needed to manufacture a certain product. Use cad software : Use computer-aided design (CAD) systems to assist in the creation, modification, analysis, or optimisation of a design. Repair medical devices : Repair or modify medical appliances and supportive devices according to the specifications. Apply technical communication skills : Explain technical details to non-technical customers, stakeholders, or any other interested parties in a clear and concise manner. Perform project management : Manage and plan various resources, such as human resources, budget, deadline, results, and quality necessary for a specific project, and monitor the project’s progress in order to achieve a specific goal within a set time and budget. Program firmware : Program permanent software with a read-only memory (ROM) on a hardware device, such as an integrated circuit. Operate precision machinery : Operate machinery used for the making of small systems or components with a high level of precision. Maintain safe engineering watches : Observe principles in keeping an engineering watch. Take over, accept and hand over a watch. Perform routine duties undertaken during a watch. Maintain the machinery space logs and the significance of the readings taken. Observe safety and emergency procedures. Observe safety precautions during a watch and take immediate actions in the event of fire or accident, with particular reference to oil systems. Train employees : Lead and guide employees through a process in which they are taught the necessary skills for the perspective job. Organise activities aimed at introducing the work and systems or improving the performance of individuals and groups in organisational settings. Prepare assembly drawings : Create the drawings that identify the different components and materials, and that provide instructions as to how they should be assembled. Perform resource planning : Estimate the expected input in terms of time, human and financial resources necessary to achieve the project objectives. Develop product design : Convert market requirements into product design and development.

ISCO group and title

2152 – Electronics engineers

• Medical device engineer – ESCO

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Medical Devices - Research and Development

Master of engineering (m. eng.).

In recent years, Medical Engineering has gained in significance and has proven to be a recession-proof and innovative sector. We are all getting older and healthcare – and medical progress – require competent, well-trained specialists. With our consecutive Master's degree program Medical Devices - Research and Development (MMD), you can make a contribution to medical progress and take on responsibility for people's future and health by developing and improving medical equipment.

The degree program is structured in three semesters and follows on from a successfully-completed Bachelor’s degree or Diploma. It aims to prepare you for challenging roles in science, research and development as well as in related areas. The course comprises the module groups “Development of Medical Products”, “Engineering Science”, “Medical Engineering”, “Simulation and Modeling” and “Management”. Depending on your preferences and previous experience, you can adapt your course individually with a project and by selecting elective modules to further your knowledge in a particular direction. The laboratory and project work for the course are incorporated into industrial and research projects. This ensures that the degree program stays closely-aligned with the latest research. Quality management of teaching and research and regular evaluations guarantee your education will be of a high standard.

The following video will show you what is special about the degree program MMD, and which characteristics you as a student will need for it.

What to expect

The focus of our course is in line with industrial requirements, and includes approval of medical products (e.g. the current European Medical Device Directive, FDA,...), modern, computer-assisted development techniques (e.g. image processing, FEM,..), as well as a Master's project running parallel to lectures (e.g. project management, design of experiments, statistics and management).

Our course content is closely aligned with the research topics " Biotechnology Instrumentation ", "Biomechatronics" and " Diagnostics- and Therapy Systems, E-Health ". Practically-oriented projects and theses withresearch partners from industry will give you the best possible preparation for your career. You can also do a doctoral degreeif your grades are good enough.

To help make your decision easier, the interview will be combined with an information event and a tour of our laboratories. You will also get the chance to chat with our professors, staff and students. We look forward to receiving your application .

Do you still have questions about applying? Find all the answers in the Online Application FAQs .

Prerequisites

You can apply for the Master’s degree program MMD if you have an above-average qualification from a technically-oriented degree course. The specialization in Medical Devices - Research and Development requires fundamental knowledge of this area, which must be acquired via additional courses if necessary.

Course schedule

The three-semester full-time course has a modular structure. You can select the elective modules and the alternative module from a catalog, in line with your personal interests and preferences. Additional classes in engineering, science and medicine are offered during the semester, enabling you to fill any gaps in your knowledge. After successful completion of the degree program, you will be awarded the academic degree title “Master of Engineering”.​

Module list

Career prospects

The market prospects for medical products are increasing: due to demographic developments in industrialized countries and due to increased industrialization in emerging economies – resulting in growing demands upon the healthcare system. The German medical engineering industry is a global leader. Highly-qualified experts and managers with specialist knowledge are always sought-after here.

The internationally-recognized Master’s qualification meets these demands. With this Master’s qualification, you will improve your career prospects and have an excellent chance of finding a job in research and development, as a project leader or manager in an international organization. Alongside development and innovation management, potential careers include system development and medical engineering management, IT processes and imaging techniques, development and research in medical engineering, simulation-based development processes, diagnostics, and process and quality management. Furthermore, the Master’s qualification enables you to do a doctoral degree and qualifies you for entry into the civil service on the “höheren Dienst” career path.​

Certified quality

By deciding to undertake a quality-assured degree program at Ulm University of Applied Sciences you are well prepared for the future. All the Bachelor's and Master's degree courses are accredited. As part of the accreditation, the feasibility of the degree program, the contents of the course of study and the suitability of the course's graduates for the requirements of their future careers are assessed. This means that you will receive a degree qualification which is recognized and quality-certified, which will help you with the recognition of your degree program – both nationally and internationally. The accreditation of the degree programs at the Ulm University of Applied Sciences offers students and employers a reliable guide regarding the quality of the degree programs.

Application

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Drug and Device Development

The Stanford Maternal and Child Health Research Institute is dedicated  to guiding Stanford investigators in the maturation of breakthrough therapies through proof-of-concept studies and commercialization.

Drug and Device Development Service

The Drug and Device Development Service exists to advance cutting edge therapies and technologies generated by the Stanford community to benefit the advancement of care to mothers and children.

MCHRI supports investigators with streamlining product development, reducing risk and increasing valuation, including:

Regulatory Strategy Target Profile Development Path from Bench to Bedside

Market Assessment Existing/Competing Solutions Market Sizing and Clinical Impact

Project Management Timeline Development Budget Building/Tracking

Click here to learn more>>

FACILITATION

MCHRI guides health innovations through the regulatory and medical development landscapes, including:

Regulatory Interactions IND/IDE Preparation and Maintenance

Funding Opportunities Exploration and Evaluation

Innovation Business Development Engagement with VC and Industry

MCHRI designs and coordinates educational opportunities to benefit translational medicine scientists at Stanford, featuring:

Career Development Eureka Certificate Course in Translational Medicine

Drug & Device Development (D 3 ) Training

Topic Discussions Webinars and Live Presentations

Grant Wells, MS Director of Innovation & Development [email protected]

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CDRH Issues 2024 Safety and Innovation Reports

Reports highlight CDRH actions to advance medical device safety and innovation and build on these efforts this year.

FOR IMMEDIATE RELEASE April 17, 2024

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH)

Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers.

As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices.

Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program , the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009.

In parallel, we took significant actions to improve device safety and enhanced our ability to identify and address new safety signals. We achieved an ambitious set of goals outlined in our 2018 Medical Device Safety Action Plan to help ensure patient safety throughout the Total Product Life Cycle (TPLC) of a medical device. We made improvements and updates to our medical device reporting programs, including updating the Manufacturer and User Facility Device Experience (MAUDE) database, vastly improved our recalls program, and took steps to ensure the timely communication and resolution of new or known safety issues.

And throughout, we partnered with patients and incorporated their voices into our work, including establishing our Patient Science and Engagement Program, because at the end of the day, improving the health and the quality of life of people is at the core of our public health mission.

We are proud of the progress we've made to advance innovation and improve the safety of medical devices, and we continue to build on these efforts, as resources and additional capabilities permit. One of the challenges we face, though, is the sheer volume of products and producers. Today there about 257,000 different types of medical devices on the U.S. market, made by approximately 22,000 manufacturing facilities worldwide, and CDRH authorizes roughly a dozen new or modified devices every business day. Despite that, the number of new or increased known safety issues involve only a small fraction of technologies and many can be addressed without any changes to the device itself. However, the impact to people can be significant, which is why we need to continuously take steps to advance both safety and innovation.

This year, we will take additional actions to help further ensure innovative, high-quality, safe, and effective devices are developed and marketed to U.S. patients. As further detailed in the 2024 Innovation Report, three actions we plan to take this year include: reimagining our premarket review program, expanding our footprint in geographical innovation centers, and launching a new home as a health care hub to extend first-class care into the home. Additionally, as detailed in the 2024 Safety Report, three actions we plan to take this year include: expanding a program to assist companies improve their device quality efforts, strengthening active surveillance, and enhancing the medical device recall process.

Through these new actions and the work detailed in the 2024 Safety and Innovation reports, CDRH remains committed to furthering our mission to protect and promote the public health and ensure our organization is well-positioned to meet the needs of all people and changes in the medical device ecosystem.

Additional Resources:

• 2024 Innovation Report
• 2024 Safety Report
• 2018 Medical Device Safety Action Plan

Robotic nerve 'cuffs' could help treat a range of neurological conditions

Researchers have developed tiny, flexible devices that can wrap around individual nerve fibres without damaging them.

The researchers, from the University of Cambridge, combined flexible electronics and soft robotics techniques to develop the devices, which could be used for the diagnosis and treatment of a range of disorders, including epilepsy and chronic pain, or the control of prosthetic limbs.

Current tools for interfacing with the peripheral nerves -- the 43 pairs of motor and sensory nerves that connect the brain and the spinal cord -- are outdated, bulky and carry a high risk of nerve injury. However, the robotic nerve 'cuffs' developed by the Cambridge team are sensitive enough to grasp or wrap around delicate nerve fibres without causing any damage.

Tests of the nerve cuffs in rats showed that the devices only require tiny voltages to change shape in a controlled way, forming a self-closing loop around nerves without the need for surgical sutures or glues.

The researchers say the combination of soft electrical actuators with neurotechnology could be an answer to minimally invasive monitoring and treatment for a range of neurological conditions. The results are reported in the journal Nature Materials .

Electric nerve implants can be used to either stimulate or block signals in target nerves. For example, they might help relieve pain by blocking pain signals, or they could be used to restore movement in paralysed limbs by sending electrical signals to the nerves. Nerve monitoring is also standard surgical procedure when operating in areas of the body containing a high concentration of nerve fibres, such as anywhere near the spinal cord.

These implants allow direct access to nerve fibres, but they come with certain risks. "Nerve implants come with a high risk of nerve injury," said Professor George Malliaras from Cambridge's Department of Engineering, who led the research. "Nerves are small and highly delicate, so anytime you put something large, like an electrode, in contact with them, it represents a danger to the nerves."

"Nerve cuffs that wrap around nerves are the least invasive implants currently available, but despite this they are still too bulky, stiff and difficult to implant, requiring significant handling and potential trauma to the nerve," said co-author Dr Damiano Barone from Cambridge's Department of Clinical Neurosciences.

The researchers designed a new type of nerve cuff made from conducting polymers, normally used in soft robotics. The ultra-thin cuffs are engineered in two separate layers. Applying tiny amounts of electricity -- just a few hundred millivolts -- causes the devices to swell or shrink.

The cuffs are small enough that they could be rolled up into a needle and injected near the target nerve. When activated electrically, the cuffs will change their shape to wrap around the nerve, allowing nerve activity to be monitored or altered.

"To ensure the safe use of these devices inside the body, we have managed to reduce the voltage required for actuation to very low values," said Dr Chaoqun Dong, the paper's first author. "What's even more significant is that these cuffs can change shape in both directions and be reprogrammed. This means surgeons can adjust how tightly the device fits around a nerve until they get the best results for recording and stimulating the nerve."

Tests in rats showed that the cuffs could be successfully placed without surgery, and they formed a self-closing loop around the target nerve. The researchers are planning further testing of the devices in animal models, and are hoping to begin testing in humans within the next few years.

"Using this approach, we can reach nerves that are difficult to reach through open surgery, such as the nerves that control, pain, vision or hearing, but without the need to implant anything inside the brain," said Barone. "The ability to place these cuffs so they wrap around the nerves makes this a much easier procedure for surgeons, and it's less risky for patients."

"The ability to make an implant that can change shape through electrical activation opens up a range of future possibilities for highly targeted treatments," said Malliaras. "In future, we might be able to have implants that can move through the body, or even into the brain -- it makes you dream how we could use technology to benefit patients in future."

The research was supported in part by the Swiss National Science Foundation, the Cambridge Trust, and the Engineering and Physical Sciences Research Council (EPSRC), part of UK Research and Innovation (UKRI).

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Story Source:

Materials provided by University of Cambridge . The original text of this story is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License . Note: Content may be edited for style and length.

Journal Reference :

• Chaoqun Dong, Alejandro Carnicer-Lombarte, Filippo Bonafè, Botian Huang, Sagnik Middya, Amy Jin, Xudong Tao, Sanggil Han, Manohar Bance, Damiano G. Barone, Beatrice Fraboni, George G. Malliaras. Electrochemically actuated microelectrodes for minimally invasive peripheral nerve interfaces . Nature Materials , 2024; DOI: 10.1038/s41563-024-01886-0

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