Medical Device Engineer Job Description [Updated for 2025]

In an era of advancing healthcare technology, the role of medical device engineers is crucial and highly sought after.

With each innovation, the demand for skilled professionals who can design, develop, and maintain our medical equipment grows exponentially.

But what exactly does a medical device engineer do?

Whether you are:

• A job seeker trying to understand the core aspects of this role,
• A hiring manager outlining the perfect candidate,
• Or simply curious about the intricacies of medical device engineering,

You’ve come to the right place.

Today, we present a versatile medical device engineer job description template, structured for effortless posting on job boards or career sites.

Let’s delve right into it.

Medical Device Engineer Duties and Responsibilities

Medical Device Engineers work at the intersection of medicine, engineering, and biotechnology.

They design, test, and implement medical devices that are used in the healthcare industry, and also ensure these devices meet all necessary regulations and standards.

Their duties and responsibilities include:

• Designing and developing medical devices such as prosthetics, implants, instruments, and equipment
• Conducting research on the engineering aspects of the biological systems of humans and animals
• Testing and validating the functionality of medical devices to ensure they are safe and effective
• Performing failure analyses and troubleshooting for medical devices
• Preparing documentation for regulatory submissions
• Ensuring compliance with all relevant medical and healthcare regulations and standards
• Interacting with doctors, therapists, and patients to get feedback on device functionality
• Working closely with manufacturers to oversee the production of medical devices
• Continuously updating knowledge on medical advancements and regulatory changes

 

Medical Device Engineer Job Description Template

Job Brief

We are seeking a dynamic and innovative Medical Device Engineer to join our team.

The ideal candidate will be responsible for the design, development, testing and implementation of medical devices.

They should be familiar with regulatory standards of medical devices and have the ability to apply engineering principles to the medical and biological sciences.

 

Responsibilities

• Design and develop medical devices in accordance with established project objectives
• Conduct research to develop new and improved medical devices
• Perform evaluations and analyses of design to meet product specifications
• Create and maintain project documentation including design history files and technical files
• Ensure compliance with all internal and external safety and quality standards
• Conduct risk analyses and design verification testing
• Assist in preparation of regulatory submissions
• Work with cross-functional teams to ensure effective product development and implementation
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products

 

Qualifications

• BSc degree in Biomedical Engineering, Mechanical Engineering or a relevant field
• Proven experience in medical device engineering
• Knowledge of FDA, EU MDR and ISO regulations related to medical devices
• Experience with 3D CAD modelling software
• Strong problem-solving and project management abilities
• Excellent written and verbal communication skills
• Ability to work in a team and independently

 

Benefits

• 401(k) plan
• Healthcare coverage including medical, dental and vision insurance
• Life insurance
• Paid time off and holidays
• Professional development opportunities

 

Additional Information

• Job Title: Medical Device Engineer
• Work Environment: Office setting with occasional travel required for client meetings and site visits. Laboratory work may also be involved.
• Reporting Structure: Reports to the Head of Engineering or Project Manager.
• Salary: Compensation is based on candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $80,000 minimum to $120,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume along with a cover letter detailing your qualifications and experience to [email address or application portal].

 

What Does a Medical Device Engineer Do?

Medical Device Engineers primarily work in the medical equipment manufacturing industry, research organizations, or healthcare facilities.

They can also work as independent consultants.

They collaborate with healthcare professionals, biomedical engineers, and other stakeholders to design, develop, and improve medical devices.

These devices can range from simple tools like stethoscopes to complex machines like MRI scanners.

Their main responsibility is to ensure the safety, reliability, and functionality of the medical devices they design.

This involves conducting rigorous tests, analyzing results, troubleshooting issues, and implementing necessary improvements.

Medical Device Engineers also play a crucial role in the compliance process.

They ensure that the devices meet all necessary regulatory standards, such as those set by the FDA and other international bodies.

They are also often involved in research and development, identifying new technologies and methods that could enhance the performance or safety of medical devices.

These professionals may also collaborate with other teams to provide technical support, assist in device installation, and train healthcare professionals in the proper use of the devices.

Medical Device Engineers continually monitor the performance of the devices, making necessary updates and modifications based on feedback from users, new technological advancements, or changes in regulatory standards.

 

Medical Device Engineer Qualifications and Skills

Medical Device Engineers utilize a combination of technical expertise, industry knowledge, and soft skills to design, develop, and test medical devices.

The following are the necessary qualifications and skills for this role:

• Strong understanding of medical device design principles, including safety and usability considerations.
• Proficiency in CAD software, simulation tools, and other engineering design software.
• Knowledge of materials used in medical devices, their properties, and their suitability for different applications.
• Strong analytical skills to conduct detailed failure analysis and identify root causes of device malfunctions.
• Excellent problem-solving skills to devise innovative solutions to complex engineering challenges.
• Familiarity with medical device regulations, standards, and quality assurance principles.
• Good communication skills to convey complex technical information to multidisciplinary teams, including non-engineers.
• Attention to detail to ensure the highest level of precision and accuracy in all work.
• Ability to work collaboratively with healthcare professionals, product managers, and other stakeholders to understand device requirements and user needs.
• Physical dexterity and good eye-hand coordination to work with small, intricate components.
• A Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.

 

Medical Device Engineer Experience Requirements

Entry-level Medical Device Engineers typically have at least 1 to 2 years of relevant experience, often obtained through internships or part-time roles in biomedical, mechanical, or electrical engineering departments.

This hands-on experience could be in the design, manufacturing, or quality testing of medical devices.

Candidates with 3 to 5 years of experience are often expected to have sharpened their technical skills and broadened their knowledge about the healthcare industry, regulatory standards, and medical device lifecycle management.

They may have worked in roles such as a Quality Assurance Engineer, Medical Device Designer, or Biomedical Engineer.

Medical Device Engineers with more than 5 years of experience are often seen as experts in their field.

They may have a proven track record in designing, developing, and implementing innovative medical devices.

At this level, they may also have accumulated leadership experience, making them suitable for supervisory or managerial roles within the medical device engineering department.

Additionally, some specialized roles may require experience with specific types of medical devices or technologies, such as implantable devices, diagnostic instruments, or surgical robotics.

 

Medical Device Engineer Education and Training Requirements

Medical Device Engineers typically have a bachelor’s degree in biomedical engineering, mechanical engineering, electrical engineering, or a closely related field.

In the curriculum, students are often exposed to areas such as biomaterials, biomechanics, bioinstrumentation, and medical imaging.

Coursework in physics, chemistry, and mathematics are also often included as these foundational subjects are critical for understanding complex engineering principles.

Depending on the responsibilities of the role, some positions may require Medical Device Engineers to have a master’s degree or PhD in a specific engineering discipline.

This is particularly true for roles involving innovative research or leadership responsibilities.

Medical Device Engineers also need a strong understanding of regulatory standards and quality assurance procedures.

Many engineers in this field seek certification from organizations such as the American Society for Quality (ASQ) to demonstrate their proficiency in these areas.

Further, ongoing education is crucial for Medical Device Engineers as technology and regulatory standards continuously evolve.

This may involve attending workshops, seminars, and training courses to stay updated on the latest advancements and changes in the field.

Experience through internships or co-op programs while in school can also be beneficial for gaining practical experience in developing and testing medical devices, and are often preferred by employers.

 

Medical Device Engineer Salary Expectations

A Medical Device Engineer can expect to earn an average salary of $89,165 (USD) per year.

However, the actual earnings can fluctuate based on factors such as expertise, years of experience, the specific type of medical devices they are specialized in, and the location of their employment.

 

Medical Device Engineer Job Description FAQs

What skills does a Medical Device Engineer need?

A Medical Device Engineer needs a strong understanding of biomedical engineering principles, excellent problem-solving skills, and the ability to work in a team.

They also require proficiency in computer-aided design (CAD) software and the ability to understand and apply regulations and standards in the medical device industry.

Strong communication skills are also essential to effectively present design ideas and collaborate with other stakeholders.

 

Do Medical Device Engineers need a specific degree?

Yes, to become a Medical Device Engineer, one typically needs a bachelor’s degree in biomedical engineering, mechanical engineering, or a related field.

Some roles may require a master’s degree or higher, especially for more advanced positions.

Additionally, an understanding or certification in medical device regulations could be beneficial.

 

What should you look for in a Medical Device Engineer’s resume?

Look for a degree in an engineering field, preferably biomedical or mechanical, and experience with CAD software.

Experience in the medical device field, including internships, projects, or prior job roles, is also essential.

Certifications from recognized bodies, such as ISO or FDA, indicating knowledge of medical device regulations would be a plus.

 

What qualities make a good Medical Device Engineer?

A good Medical Device Engineer is analytical, detail-oriented, and has a strong understanding of engineering principles.

They should be able to work collaboratively with a team and have strong communication skills to liaise with other departments and regulatory bodies.

They must also keep up-to-date with the latest trends and technologies in the medical device field and be able to adapt to changes in regulations and standards.

 

Is it difficult to hire Medical Device Engineers?

Hiring Medical Device Engineers can be challenging due to the specialized skills and knowledge required for the role.

The hiring process might be more manageable if you offer competitive salaries, opportunities for professional growth, and a work environment that encourages creativity and innovation.

 

Conclusion

And there you have it.

Today, we’ve illuminated the intricate details of what it means to be a medical device engineer.

Surprising, isn’t it?

It’s not just about designing devices.

It’s about shaping the future of healthcare, one medical device at a time.

With our reliable medical device engineer job description template and real-life examples, you’re ready to make your mark.

But why not go the extra mile?

Unearth more with our job description generator. It’s your next step to meticulous job listings or refining your resume to perfection.

Always remember:

Each medical device you create is a part of the larger healthcare landscape.

Let’s advance that future. Together.

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