Medical Devices Embedded Software Engineer Job Description [Updated for 2025]

In the era of medical advancements, the importance of medical devices embedded software engineers has never been more critical.

As medical technology progresses, the demand for proficient minds who can design, develop, and secure our medical device software strengthens.

But let’s delve deeper: What’s really expected from a medical devices embedded software engineer?

Whether you are:

• A job seeker attempting to understand the core responsibilities of this role,
• A hiring manager formulating the perfect candidate profile,
• Or simply fascinated by the complex world of medical device software engineering,

You’ve come to the right place.

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

Let’s dive in.

Medical Devices Embedded Software Engineer Duties and Responsibilities

Medical Devices Embedded Software Engineers focus on developing software for medical devices that require embedded systems.

They work closely with various teams and stakeholders to ensure that the software meets regulatory standards and fulfills the needs of the end-users.

The duties and responsibilities of a Medical Devices Embedded Software Engineer include:

• Designing and implementing software of embedded devices and systems
• Developing, coding, testing, and debugging system software
• Supporting software QA and optimize I/O performance
• Reviewing code and design, and integrating and validating new product designs
• Analyzing and enhancing efficiency, stability, and scalability of system resources
• Providing post-production support and troubleshooting to resolve system errors
• Ensuring the alignment of software with medical regulations and standards
• Collaborating with other departments such as hardware engineers and medical scientists to ensure the functionality and reliability of the devices
• Documenting software specifications and training users
• Maintaining knowledge of current trends and technological advancements in embedded systems

 

Medical Devices Embedded Software Engineer Job Description Template

Job Brief

We are seeking a dedicated and detail-oriented medical devices embedded software engineer to develop, implement, and optimize software embedded in medical devices.

This role involves understanding hardware design, developing embedded software applications, debugging, and testing.

The ideal candidate will be familiar with the full software development life cycle, from preliminary system analysis to tests and deployment, with particular focus on safety-critical and regulated environments.

 

Responsibilities

• Design, develop and optimize embedded software for medical devices
• Collaborate with cross-functional teams to define software requirements and interfaces
• Conduct code reviews to ensure compliance with quality standards
• Develop and execute unit and integration tests
• Create and maintain documentation for software designs and code
• Support hardware engineers in microcontroller-based hardware design
• Comply with medical device software development procedures and regulations
• Troubleshoot and resolve software-related issues
• Stay updated with the latest trends and technology in embedded software

 

Qualifications

• Proven work experience as an embedded software engineer, preferably in the medical devices industry
• Proficiency in embedded software programming languages like C, C++
• Experience with microcontrollers and interfacing peripherals
• Knowledge of software development for regulated environments, specifically FDA and ISO standards
• Familiarity with real-time operating systems
• Experience with software version control systems
• Excellent problem-solving and analytical skills
• BSc degree in Computer Science, Electronic Engineering or a related field

 

Benefits

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

 

Additional Information

• Job Title: Medical Devices Embedded Software Engineer
• Work Environment: Office setting with options for remote work. Occasional travel may be required for team meetings or client consultations.
• Reporting Structure: Reports to the Lead Software Engineer or Software Development Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $92,000 minimum to $135,000 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 Embedded Software Engineer Do?

Medical Devices Embedded Software Engineers work primarily in the healthcare industry, for companies that design and manufacture medical devices.

They can also work for IT firms that specialize in healthcare technology solutions.

Their role involves designing, developing, coding, testing, and debugging software that’s embedded in medical devices.

This could include devices such as pacemakers, insulin pumps, or diagnostic equipment.

These engineers work closely with other professionals such as Electronic Engineers, Systems Analysts, and Medical Scientists, to understand the hardware aspects and the clinical requirements of the devices they are working on.

They use this knowledge to create software that drives the device’s functionality.

They are also responsible for ensuring that the software complies with all relevant medical device regulations and standards, such as those relating to safety and security.

In addition to creating new software, Medical Devices Embedded Software Engineers also maintain and improve existing software.

They perform regular updates, fix bugs, and adapt the software to accommodate changes in hardware or clinical practice.

Furthermore, they may also be tasked with creating documentation for the software, which could be used for regulatory submissions, user manuals, or maintenance guides.

 

Medical Devices Embedded Software Engineer Qualifications and Skills

A Medical Devices Embedded Software Engineer utilizes a blend of technical skills, industry knowledge and soft skills to design, create, and maintain embedded software for medical devices.

Key qualifications and skills required include:

• Proficiency in programming languages such as C, C++, or Assembly necessary for embedded systems development.
• A strong understanding of hardware and software integration, able to debug and troubleshoot effectively.
• Experience with real-time operating systems and microcontroller programming.
• Knowledge of safety-critical standards, such as ISO 13485 or IEC 62304, which are applicable to medical device software.
• Strong analytical skills to identify potential design flaws and improve system performance.
• Superb communication skills to collaborate with hardware engineers, software engineers, and other team members, as well as explain complex technical issues to non-technical stakeholders.
• Strong attention to detail, necessary for ensuring that the embedded software operates as intended and meets regulatory requirements.
• Problem-solving skills to efficiently identify and resolve issues that arise during the design, testing, and maintenance processes.
• Understanding of medical device industry and the specific requirements for software in this domain.

 

Medical Devices Embedded Software Engineer Experience Requirements

Entry-level candidates for the role of a Medical Devices Embedded Software Engineer often have between 1 to 3 years of experience, usually obtained through internships, academic projects or part-time roles in a relevant field.

This could involve work in the development of embedded systems, software design or quality assurance in a biomedical or healthcare setting.

Candidates with 3 to 5 years of experience often have developed their technical skills, such as programming in embedded C/C++, developing software for real-time systems, and knowledge of medical device standards like ISO 13485 or IEC 62304.

They should also have experience with hardware-software integration and familiarity with medical device regulations.

Those with more than 5 years of experience in the field of medical devices embedded software engineering are often seen as senior engineers.

At this level, candidates are expected to have managed end-to-end medical device software projects, led teams, and effectively coordinated with cross-functional teams such as hardware engineering, quality assurance and regulatory affairs.

They may have a track record of successfully navigating the product development lifecycle, from concept to market release, in compliance with medical device regulations and standards.

Overall, a Medical Devices Embedded Software Engineer needs to have a strong mix of technical knowledge, practical experience and understanding of regulatory requirements in the field of medical device development.

 

Medical Devices Embedded Software Engineer Education and Training Requirements

Medical Devices Embedded Software Engineers typically hold a bachelor’s degree in software engineering, computer science, electronics engineering or another related field.

This equips them with the fundamental concepts of programming and electronics.

In addition to their degree, an understanding of medical device standards and regulations, such as those set by the Food and Drug Administration (FDA), is crucial.

Familiarity with specific regulatory standards like ISO 13485, IEC 62304, or ISO 14971 can also be beneficial.

Since the work involves designing software for embedded systems, these engineers should possess a strong background in programming languages commonly used in embedded systems, such as C, C++, and Assembly language.

Understanding of Real-Time Operating Systems (RTOS) is often essential.

Specialized areas in the medical device industry, such as imaging systems or robotics, may require additional knowledge in corresponding fields, which may be acquired through postgraduate studies or specialized courses.

Furthermore, having a certification from recognized institutions, like the IEEE Computer Society or other industry-specific certification bodies, can be advantageous.

Certifications in quality management and software development processes, such as CMMI or Agile/Scrum, can also be beneficial.

The field of medical devices is rapidly evolving, so a commitment to continuous learning and staying updated with the latest technological advancements is important.

Finally, because of the critical nature of medical devices, experience in the development of safety-critical systems can be a plus, whether from prior work experience or specialized training courses.

 

Medical Devices Embedded Software Engineer Salary Expectations

A Medical Devices Embedded Software Engineer earns an average salary of $108,678 (USD) per year.

The actual salary can differ based on the individual’s experience, the company they work for, and the region they are based in.

 

Medical Devices Embedded Software Engineer Job Description FAQs

What skills does a Medical Devices Embedded Software Engineer need?

In addition to solid coding skills, a Medical Devices Embedded Software Engineer should have a strong understanding of medical device standards and regulations.

They must have proficiency in embedded software development and debugging, and a deep knowledge of microcontroller architectures.

They should also be knowledgeable in software development methodologies and be comfortable working with hardware.

 

What is the educational requirement for a Medical Devices Embedded Software Engineer?

Typically, a bachelor’s degree in computer science, electrical engineering, or a related field is required.

Some positions may require a master’s degree or specific certifications.

Additionally, knowledge of medical device software development and FDA regulations is essential.

 

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

A strong candidate will have experience in embedded software development, preferably in the medical device industry.

Look for experience with programming languages commonly used in the industry, like C or C++.

Knowledge of FDA software validation requirements and experience with real-time operating systems can also be valuable.

 

What qualities make a good Medical Devices Embedded Software Engineer?

A good Medical Devices Embedded Software Engineer should have excellent problem-solving skills and a keen eye for detail, as they’ll be responsible for identifying and troubleshooting software issues.

They should be methodical and patient, with the ability to concentrate for long periods.

Excellent communication skills are crucial, as they’ll need to explain complex technical information to other team members and stakeholders.

 

How challenging is it to hire a Medical Devices Embedded Software Engineer?

Given the specialized skills required for this role, hiring can be challenging.

There is a high demand for experienced engineers in this field, and the pool of qualified candidates may be limited.

As an employer, you may need to offer competitive salaries and benefits to attract top talent.

 

Conclusion

And there you have it.

Today, we’ve revealed the intricate workings of being a medical devices embedded software engineer.

Surprise, surprise?

It’s not only about developing software.

It’s about forging the future of healthcare, one line of code at a time.

Armed with our detailed medical devices embedded software engineer job description template and real-world examples, you’re ready to take that leap.

But why stop at the surface?

Plunge deeper with our job description generator. It’s your secret tool for creating laser-accurate listings or polishing your resume to flawlessness.

Bear in mind:

Every line of code contributes to the larger mission.

Let’s shape that future. Together.

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