Medical Device R&D Engineer Job Description [Updated for 2025]

In the era of technological advancements, the focus on Medical Device R&D Engineers is ever increasing.

As medical technology evolves, the demand for knowledgeable professionals who can invent, develop, and refine our medical devices is escalating.

But let’s dive deeper: What’s truly expected from a Medical Device R&D Engineer?

Whether you are:

• A job seeker aiming to understand the core of this role,
• A hiring manager drafting the perfect candidate profile,
• Or simply fascinated by the intricacies of medical device research and development,

You’ve come to the right place.

Today, we present a comprehensive Medical Device R&D Engineer job description template, tailored for effortless posting on job boards or career sites.

Let’s delve straight into it.

Medical Device R&D Engineer Duties and Responsibilities

Medical Device R&D Engineers are tasked with developing, designing, and enhancing medical devices for the healthcare industry.

This involves a mix of engineering, biological, and medical knowledge, as well as a deep understanding of regulatory guidelines.

The duties and responsibilities of a Medical Device R&D Engineer include:

• Collaborating with clinical advisors and researching to identify and understand the needs for new medical devices
• Designing, developing, and prototyping new medical devices using engineering principles
• Conducting design verification and validation testing in compliance with regulatory standards
• Maintaining documentation on design control and risk management activities for projects
• Ensuring medical devices meet all safety, functionality, and performance specifications
• Working with manufacturing teams to ensure design for manufacturability
• Collaborating with quality assurance teams to ensure compliance with regulatory standards such as FDA, ISO, and EU MDR
• Keeping updated with the latest technological advancements in the field of medical devices
• Presenting research findings to stakeholders and attending medical device expos or conferences

 

Medical Device R&D Engineer Job Description Template

Job Brief

We are looking for a dedicated Medical Device R&D Engineer to contribute to the creation and development of innovative medical devices.

The Medical Device R&D Engineer will be responsible for researching, designing, and developing new devices, as well as improving upon existing devices.

The ideal candidate has a strong background in biomedical engineering, is familiar with the medical device development life cycle, and has a passion for improving patient care through technological innovation.

 

Responsibilities

• Design and develop new medical devices and improve upon existing devices
• Perform research on design technologies and medical device applications
• Conduct feasibility studies for proposed devices
• Ensure all product designs meet required safety and quality standards
• Create and maintain detailed design documentation
• Perform validation and verification testing
• Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs
• Follow regulatory standards and good manufacturing practices

 

Qualifications

• Proven work experience in medical device R&D or a related field
• Strong knowledge of biomedical engineering principles
• Familiarity with medical device regulatory standards (e.g., FDA, ISO 13485)
• Excellent problem-solving and analytical skills
• Ability to work collaboratively in a team environment
• Experience with CAD software and other engineering tools
• MSc or PhD degree in Biomedical Engineering, Mechanical Engineering or a relevant field

 

Benefits

• 401(k) plan
• Comprehensive health, dental, and vision insurance
• Life insurance
• Flexible spending account (FSA) for healthcare expenses
• Paid time off (PTO)
• Professional development opportunities

 

Additional Information

• Job Title: Medical Device R&D Engineer
• Work Environment: This role is based in a laboratory environment. Occasional travel may be required for conferences or collaborations with external partners.
• Reporting Structure: Reports directly to the R&D Team Lead or Director of Engineering.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $80,000 minimum to $130,000 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 Device R&D Engineer Do?

Medical Device R&D (Research and Development) Engineers work primarily in the healthcare and biotechnology industries.

They play a crucial role in the development of new medical devices and technologies.

These engineers apply principles of engineering and life sciences to create new medical equipment or improve the functionality of existing devices.

They are involved in all stages of product development, from initial concept to final product manufacturing.

Their tasks include brainstorming innovative ideas, designing prototypes, and testing these prototypes for safety and effectiveness.

They often work in a laboratory setting, using specialized equipment and software to aid in their research and development tasks.

They collaborate closely with other professionals such as bioengineers, physicians, and regulatory affairs specialists.

This collaboration is essential to ensure the developed medical devices are not only functional and safe but also comply with industry standards and regulations.

Medical Device R&D Engineers continually review and analyze data from product trials, modifying designs as needed.

They are also responsible for documenting all phases of the development process, preparing detailed reports and presentations for stakeholders.

Furthermore, these engineers may also be involved in securing patents for new devices and technologies, ensuring the company’s intellectual property rights are protected.

In some cases, they may also provide technical support for medical devices post-launch, helping to troubleshoot issues and advising on maintenance and correct use.

Through their work, Medical Device R&D Engineers contribute significantly to advancements in medical technology and healthcare outcomes.

 

Medical Device R&D Engineer Qualifications and Skills

Medical Device R&D Engineers need a combination of technical knowledge, problem-solving abilities, communication skills and attention to detail in order to design and develop new medical devices, such as:

• Expertise in Biomedical Engineering or a related field to understand the medical device landscape and apply this knowledge to the research and development process.
• Proficiency in Computer-Aided Design (CAD) software to design and develop models for new medical devices.
• Strong analytical and problem-solving skills to troubleshoot issues in the design and development phase and to find innovative solutions to complex problems.
• Excellent communication skills to clearly convey design concepts and complex technical information to a variety of stakeholders, including product managers, manufacturers, and regulatory bodies.
• Attention to detail and strong organization skills to manage various aspects of the R&D process such as documentation, testing, and quality control.
• Knowledge of regulatory standards and compliance requirements to ensure that all devices are designed and developed according to the necessary guidelines and laws.
• Understanding of material science and electronics, as well as their application in the design of medical devices.
• Collaborative team skills to work effectively with multidisciplinary teams including doctors, scientists, and other engineers.

 

Medical Device R&D Engineer Experience Requirements

Medical Device R&D Engineers generally require a bachelor’s degree in biomedical engineering, mechanical engineering, or a related field, with an extensive focus on research, design, and development of medical devices.

At an entry-level position, they may have 1 to 2 years of experience, often obtained through an internship, co-op, or entry-level role in biomedical or mechanical design.

It is also beneficial if they have experience in a clinical or hospital setting to better understand the real-world applications of the devices they design.

Candidates with 3 to 5 years of experience often develop their technical skills and knowledge in entry-level R&D engineering roles.

These professionals may have had the opportunity to work on the full lifecycle of a medical device, from conception and design to testing and manufacturing.

Those with more than 5 years of experience typically have a deeper understanding of complex biomedical systems, as well as a broader understanding of the regulatory and quality assurance aspects of medical device development.

This level of experience often includes leadership roles, leading project teams or managing R&D departments.

In addition, due to the complexity and importance of the work, many R&D Engineers continue their education to earn a master’s or doctorate degree, further specializing their skills and knowledge in medical device design and development.

 

Medical Device R&D Engineer Education and Training Requirements

Medical Device R&D Engineers typically hold a bachelor’s degree in biomedical engineering, mechanical engineering, electrical engineering, or a related field.

In addition to this foundational education, they need to have a strong understanding of medical device regulations and quality systems, and a deep knowledge of human biology and anatomy.

Many positions require experience with design and manufacturing techniques used in medical device production, such as 3D printing, CNC machining, and injection molding.

Depending on the nature of their work, Medical Device R&D Engineers may need to be familiar with specialized software for modeling and simulation, such as SolidWorks or AutoCAD.

Some positions may require a master’s degree or Ph.D., particularly those involving highly specialized or advanced research and development tasks.

Continuing education is important in this field, and many Medical Device R&D Engineers pursue additional courses, certifications or degrees to stay current with emerging technologies and regulations in the medical device industry.

Completion of a postgraduate degree or certification in regulatory affairs, quality systems or a related area can provide a significant advantage in this competitive field.

 

Medical Device R&D Engineer Salary Expectations

The average salary for a Medical Device R&D Engineer is approximately $95,000 (USD) per year.

However, the exact salary can range significantly based on factors such as experience, specific skills, location, and the size of the employing company.

Entry-level positions may start around $70,000 (USD), while senior roles can reach up to $120,000 (USD) or more annually.

 

Medical Device R&D Engineer Job Description FAQs

What is the educational requirement for a Medical Device R&D Engineer?

A Medical Device R&D Engineer typically requires a bachelor’s degree in biomedical engineering, mechanical engineering, or a related field.

Some employers may prefer candidates with a master’s degree or a Ph.D., particularly for more advanced or specialized roles.

Practical experience through internships or co-op programs is also beneficial.

 

What skills are essential for a Medical Device R&D Engineer?

Medical Device R&D Engineers should have strong analytical and problem-solving skills to devise innovative solutions for complex medical device issues.

They should also have a good understanding of regulatory standards and quality control procedures.

Proficiency in computer-aided design (CAD) software, strong communication skills, and the ability to work in a team are also essential.

 

What does a typical day look like for a Medical Device R&D Engineer?

A typical day for a Medical Device R&D Engineer may involve conducting research, designing and testing prototypes, and troubleshooting issues with existing devices.

They may also spend time staying updated on regulatory guidelines and industry developments, writing technical reports, and collaborating with other professionals such as doctors, scientists, and other engineers.

 

What qualities make a successful Medical Device R&D Engineer?

A successful Medical Device R&D Engineer is detail-oriented and has a strong interest in healthcare and medical technology.

They are innovative, able to think critically, and use their creativity to come up with unique solutions to complex problems.

Patience and persistence are also key qualities, as the development and testing process can be lengthy and require numerous iterations.

 

How challenging is it to hire a Medical Device R&D Engineer?

Hiring a Medical Device R&D Engineer can be challenging due to the specialized nature of the role.

It requires a unique blend of engineering skills, understanding of medical technology, and knowledge of healthcare regulations.

Employers need to offer competitive compensation packages and provide opportunities for professional development to attract and retain top talent.

 

Conclusion

And there you have it.

Today, we’ve unveiled the inner workings of a medical device R&D engineer’s role.

Surprised?

It’s not just about designing medical devices.

It’s about innovating healthcare solutions, one device at a time.

With our comprehensive medical device R&D engineer job description template and real-world examples, you’re ready to take the leap.

But why halt your progress?

Venture further with our job description generator. It’s your ultimate tool for creating meticulously detailed listings or fine-tuning your resume to perfection.

Remember:

Every medical device you design is a step towards a healthier future.

Let’s innovate that future. Together.

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