Medical Devices Engineer Job Description [Updated for 2025]

In the ever-evolving field of healthcare, the importance of medical devices engineers is increasingly paramount.

As medical technology advances, the demand for innovative minds who can design, optimize, and maintain our medical equipment becomes critical.

But let’s delve deeper: What’s truly expected from a medical devices engineer?

Whether you are:

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

You’re in the right place.

Today, we present a customizable medical devices engineer job description template, tailored for effortless posting on job boards or career websites.

Let’s get started.

Medical Devices Engineer Duties and Responsibilities

Medical Devices Engineers are responsible for the design, development, and testing of medical equipment and devices.

They work closely with medical professionals to ensure that the products meet specific medical needs.

Their duties and responsibilities include:

• Designing and developing medical diagnostic and clinical instrumentation, equipment, and procedures
• Utilizing the principles of engineering and biomedical sciences to evaluate the safety, efficiency, and effectiveness of medical devices
• Testing and validating the functionality of medical devices
• Preparing procedures, write technical reports, publish research papers, and make recommendations based on their research findings
• Communicating with doctors and medical researchers to determine the needs of the end-user
• Creating prototypes and simulations of medical devices
• Conducting research to solve clinical problems using both theory and practical approaches
• Adhering to regulatory standards, including FDA regulations, during the design and development process
• Implementing or testing design solutions for devices used by healthcare professionals
• Working with manufacturers to ensure that design specifications are implemented during the manufacturing process

 

Medical Devices Engineer Job Description Template

Job Brief

We are seeking a skilled and dedicated Medical Devices Engineer to design, develop, and implement medical devices.

The Medical Devices Engineer will be responsible for testing, evaluation, and improvement of existing medical devices, as well as the conceptualization and development of new devices.

Candidates should be highly knowledgeable in biomedical engineering principles, medical device regulations and standards, and possess the ability to apply engineering skills and scientific principles to biological and medical problems.

The ultimate goal of the Medical Devices Engineer is to produce high-quality, innovative, and fully functioning medical devices that improve patient care and health outcomes.

 

Responsibilities

• Design and develop medical devices using principles of biomedical engineering.
• Conduct testing and evaluation of devices to ensure functionality and safety.
• Collaborate with medical professionals to understand their needs and develop appropriate solutions.
• Create technical documents and reports to detail device specifications and testing results.
• Ensure compliance with all local, national, and international regulations and standards for medical devices.
• Identify opportunities for improvements to existing devices and develop innovative solutions.
• Provide technical support and training for medical professionals using the devices.
• Work closely with production teams to ensure devices are produced to exact specifications.

 

Qualifications

• Degree in Biomedical Engineering, or a related field.
• Proven experience in Medical Devices Engineering or related field.
• Knowledge of biomedical engineering principles and medical device regulations.
• Strong technical and problem-solving skills.
• Excellent communication and collaboration abilities.
• Attention to detail and a strong focus on patient safety and product quality.

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Medical Devices Engineer
• Work Environment: Lab and office setting, with some field visits. Some travel may be required for device trials or professional meetings.
• Reporting Structure: Reports to the Lead Biomedical Engineer or Medical Devices Engineering Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $100,000 minimum to $160,000 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 and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Medical Devices Engineer Do?

Medical Devices Engineers primarily work in medical technology companies, research institutions, hospitals, and regulatory agencies.

They also work as independent consultants.

They are primarily responsible for the design, development, and testing of medical equipment, such as prosthetics, implants, imaging devices like MRI machines, and medical instruments.

These professionals collaborate with other engineers, medical professionals, and scientists to understand the requirements for new devices or improvements on existing ones.

Medical Devices Engineers also use computer software to design and analyze the efficiency of devices.

They are responsible for prototyping, testing, and refining devices based on the feedback received.

They ensure that the medical devices meet all the regulatory standards, safety requirements, and are cost-effective.

Medical Devices Engineers often work on improving the functionality and efficiency of existing devices based on clinical feedback.

They also work on ensuring the devices are user-friendly for the medical staff and comfortable for patients.

Finally, they provide technical support for the devices they develop and often train medical staff on the correct usage of these devices.

 

Medical Devices Engineer Qualifications and Skills

Medical Devices Engineers apply a combination of technical skills, industry knowledge, and soft skills to design, maintain, and improve medical equipment and devices.

Essential qualifications and skills include:

• Thorough knowledge of biomedical engineering principles and the ability to apply this knowledge in the design and improvement of medical devices.
• Excellent problem-solving skills to identify design flaws or issues in medical devices and create effective solutions.
• Attention to detail to ensure that medical devices meet regulatory standards and are safe and effective for patient use.
• Strong computer skills, particularly in software programs commonly used in medical device design such as Computer-Aided Design (CAD) and Computer-Aided Manufacturing (CAM).
• Understanding of medical regulations and standards to ensure compliance in all aspects of device design and manufacturing.
• Excellent communication skills to effectively collaborate with other engineers, healthcare professionals, and regulatory bodies. This is also important for explaining complex technical details to non-technical colleagues and clients.
• Ability to work under pressure and manage multiple projects concurrently, utilizing effective time management skills.
• Strong analytical skills for conducting research and analyzing data, which is essential in the testing and validation process of medical devices.

 

Medical Devices Engineer Experience Requirements

Entry-level candidates for Medical Devices Engineer roles usually have at least 1 to 2 years of experience, typically gained through internships or part-time roles in biomedical engineering or related fields.

Their experience should ideally involve some exposure to medical device design, development, testing, and quality assurance.

Candidates with 3 to 5 years of experience often have deeper knowledge in the field of biomedical engineering, specifically in the area of medical devices.

They often have experience in designing, developing, and testing medical devices, maintaining relevant documentation, and ensuring adherence to regulatory requirements.

Those with more than 5 years of experience in medical devices engineering often have substantial technical expertise and may have overseen complete life-cycles of medical device development.

They often have experience in project management, team leadership, and regulatory affairs.

They may be ready for roles involving greater responsibility, such as a team leader, project manager, or senior engineer in the medical devices field.

Regardless of the level, all candidates should be familiar with the regulatory standards and guidelines related to the development and marketing of medical devices, such as those from the FDA or the European Union’s Medical Device Regulation (MDR).

Relevant certifications, like Certified Biomedical Auditor (CBA) or Regulatory Affairs Certification (RAC), can be beneficial.

 

Medical Devices Engineer Education and Training Requirements

Medical Devices Engineers typically require a bachelor’s degree in biomedical engineering or a related field, such as mechanical or electrical engineering with a concentration in biomedical engineering.

They must have a solid understanding of medical sciences, engineering principles, biology, and chemistry.

These professionals should also be well-versed in regulatory requirements for medical devices.

For more complex or senior roles, a master’s degree in biomedical engineering or a related discipline may be required.

This advanced education often specializes in a specific aspect of medical devices such as design, development, or regulatory affairs.

In addition to formal education, hands-on training and experience in the design and development of medical devices are highly beneficial.

This could be gained through internships, cooperative education programs, or entry-level positions in the field.

Continuing education or professional certifications are also valued in this field.

They demonstrate a commitment to keeping up to date with the latest advances in technology and regulatory changes affecting the medical devices industry.

Lastly, Medical Devices Engineers may need to be licensed, particularly if they offer their services directly to the public.

This usually requires a degree from an accredited engineering program, relevant work experience, and passing scores on the Fundamentals of Engineering (FE) and Professional Engineering (PE) exams.

 

Medical Devices Engineer Salary Expectations

A Medical Devices Engineer can expect to earn an average salary of $91,000 (USD) per year.

However, this figure can vary greatly depending on factors like the engineer’s level of experience, the size and prestige of their employing company, and the region in which they work.

 

Medical Devices Engineer Job Description FAQs

What are the essential skills for a Medical Devices Engineer?

Medical Devices Engineers should have strong knowledge in bio-materials, biomechanics, and medical device design.

They should possess problem-solving abilities and attention to detail, which is crucial in designing and testing medical devices.

They should also have strong communication and interpersonal skills for collaborating with doctors, scientists, and manufacturers, and for explaining complex technical information to non-engineers.

 

What qualifications do Medical Devices Engineers need?

A Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or a related field is typically required for entry-level positions in Medical Devices Engineering.

Many employers also prefer candidates with a Master’s degree or PhD, particularly for more advanced roles.

Additionally, Medical Devices Engineers may need to be licensed, particularly if they are providing services directly to the public.

 

What should you look for in a Medical Devices Engineer resume?

A strong Medical Devices Engineer resume should highlight a solid educational background in a relevant engineering field, and demonstrate the candidate’s expertise in designing, developing, and testing medical devices.

Any certifications related to medical device regulation, such as a Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA), would be a plus.

Experience in working with cross-functional teams and proficiency in software such as CAD or MATLAB would also be beneficial.

 

What qualities make a good Medical Devices Engineer?

A good Medical Devices Engineer should have a strong analytical mind and problem-solving skills, as they are often required to find innovative solutions to complex issues.

They should also be detail-oriented and meticulous, as precision is crucial in the design and testing of medical devices.

Good communication skills are also important, as they need to collaborate with various professionals, including clinicians, manufacturers and regulatory specialists.

 

Is it difficult to hire a Medical Devices Engineer?

Hiring a Medical Devices Engineer can be challenging due to the specialized nature of the role.

It requires a combination of engineering expertise and a deep understanding of biological systems and medical regulations.

Therefore, finding professionals with the right balance of technical skills and medical knowledge can be difficult.

To attract top talent, companies may need to offer competitive salaries, opportunities for professional development, and challenging projects that make a difference in healthcare.

 

Conclusion

There you have it.

Today, we’ve revealed the true essence of being a medical devices engineer.

And guess what?

It’s not just about technical specifications and blueprints.

It’s about creating life-saving devices, one component at a time.

With our comprehensive medical devices engineer job description template and tangible examples, you’re ready to take the next step.

But why limit yourself?

Venture further with our job description generator. It’s your go-to tool for perfecting meticulously-detailed listings or fine-tuning your resume to precision.

Always remember:

Each device component contributes to the bigger picture.

Let’s innovate healthcare. Together.

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