Medical Devices Reliability Engineer Job Description [Updated for 2025]

In the ever-evolving healthcare industry, the demand for medical devices reliability engineers has never been more critical.

Medical technology continues to advance, and with each innovation, the need for proficient minds who can develop, enhance, and ensure the reliability of our medical devices grows exponentially.

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

Whether you are:

• A job seeker trying to understand the crux of this role,
• A hiring manager crafting the ideal candidate profile,
• Or simply fascinated by the technicalities of medical device engineering,

You’re in the right place.

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

Let’s dive right in.

Medical Devices Reliability Engineer Duties and Responsibilities

Medical Devices Reliability Engineers are responsible for ensuring the safety, efficacy and reliability of medical devices.

They play a crucial role in the design, testing, and maintenance of medical equipment.

Their duties and responsibilities include:

• Working with design teams to develop medical devices that are reliable, safe, and effective
• Designing and implementing testing procedures to verify the reliability of medical devices
• Analyzing data from reliability tests and creating reports for the medical device manufacturers
• Identifying potential failures in medical devices and working with teams to correct these problems
• Ensuring compliance with industry standards and regulations for medical devices
• Maintaining documentation on reliability tests, device failures, and corrections
• Providing technical support to healthcare professionals and customers
• Working on improving the reliability of existing medical devices through design modifications and testing
• Keeping up-to-date with the latest technological advancements and trends in the field of medical devices

 

Medical Devices Reliability Engineer Job Description Template

Job Brief

We are looking for a dedicated and meticulous Medical Devices Reliability Engineer to join our team.

In this role, you will be responsible for the continuous improvement of our medical devices, ensuring their reliability and performance.

You will be working closely with a team of engineers and medical professionals to conduct reliability assessments, perform root cause failure analyses, and implement robust reliability testing protocols.

Your goal will be to ensure all our medical devices meet the highest standards of quality, reliability, and safety.

 

Responsibilities

• Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts
• Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives
• Identify and manage asset reliability risks that could adversely affect operations or business goals
• Design and execute reliability tests on medical devices
• Perform root cause failure analysis on failed medical devices
• Collaborate with design engineers to enhance the reliability of new products
• Ensure all medical devices comply with international quality and safety standards

 

Qualifications

• Proven work experience as a Reliability Engineer, preferably in the medical devices industry
• Excellent understanding of reliability, maintenance, and risk management strategies
• Strong problem-solving and analytical skills
• Familiarity with reliability analysis and prediction tools
• Proficiency in using statistical software and databases
• A degree in Engineering, preferably in Biomedical, Mechanical, or Electrical Engineering

 

Benefits

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

 

Additional Information

• Job Title: Medical Devices Reliability Engineer
• Work Environment: This role requires working in an office setting, laboratories, and some field work may be required.
• Reporting Structure: Reports to the Reliability Engineering Manager 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 Devices Reliability Engineer Do?

Medical Devices Reliability Engineers are specialized professionals who work in the medical devices industry.

They are primarily engaged in the design, development, and validation of medical devices.

They focus on ensuring the reliability and safety of medical devices, from simple tools like blood pressure monitors to complex devices like defibrillators and imaging machines.

Their job involves conducting reliability tests, failure mode and effects analysis (FMEA), and risk assessments.

They use statistical analysis tools to understand data trends and predict potential failure modes.

Furthermore, they are responsible for developing and implementing corrective and preventive actions to improve device reliability.

Medical Devices Reliability Engineers closely work with quality assurance teams, manufacturers, and other stakeholders to ensure that the devices meet industry standards, regulatory requirements, and user needs.

They may also be involved in providing training to other engineers and technicians about reliability principles and practices.

The work of Medical Devices Reliability Engineers is critical as it directly impacts the safety and well-being of patients using the medical devices.

Their role requires a strong background in engineering principles, knowledge of medical device regulations, and excellent problem-solving skills.

 

Medical Devices Reliability Engineer Qualifications and Skills

A competent Medical Devices Reliability Engineer should possess a myriad of skills and qualifications that match the requirements of the role, including:

• Proficiency in performing reliability tests and stress tests on medical devices to ensure their long-term functionality and compliance with industry standards.
• Strong engineering knowledge to understand, design, and improve medical devices.
• Excellent problem-solving skills to identify potential issues in medical devices and implement effective solutions.
• Ability to work cross-functionally with other teams such as Design, Production, Quality Assurance, and Regulatory Affairs to ensure product reliability and safety.
• Strong analytical skills for interpreting testing data and making data-driven decisions to improve product reliability.
• Detailed understanding of medical device regulations and standards, such as FDA, ISO 13485, and ISO 14971 to ensure compliance.
• Excellent communication skills to clearly explain complex engineering concepts to stakeholders and team members.
• Proficiency in using various engineering software and tools for simulation, testing, and data analysis.
• Ability to manage multiple projects simultaneously and pay keen attention to details to deliver accurate and reliable results.
• A Bachelor’s Degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field, along with relevant work experience in the medical device industry.

 

Medical Devices Reliability Engineer Experience Requirements

Entry-level candidates for the role of a Medical Devices Reliability Engineer may have one to two years of experience, possibly obtained through an internship or part-time role in biomedical engineering or a related field.

These professionals may also gain practical experience in roles such as Biomedical Technician, Medical Devices Quality Assurance Associate, or other healthcare technology-related roles.

Candidates with more than three years of experience are often equipped with a strong technical understanding of medical device development, testing, and reliability evaluation.

They may have developed these skills in roles such as Medical Devices Engineer, Biomedical Engineer, or Quality Assurance Engineer.

Those with more than five years of experience are likely to have significant experience in the design, testing, and quality assurance of medical devices.

They may also have leadership experience and could be prepared for a managerial or team-lead role in the medical devices engineering field.

Regardless of years of experience, a Medical Devices Reliability Engineer should possess a deep understanding of FDA regulations and ISO standards related to medical devices, as well as proficiency in risk management and statistical analysis techniques.

 

Medical Devices Reliability Engineer Education and Training Requirements

Medical Devices Reliability Engineers typically hold a bachelor’s degree in biomedical engineering, electrical engineering, mechanical engineering, or a closely related field.

In their course of study, they learn about the human biological systems, medical devices, and quality and reliability engineering principles.

They are also trained to use specialized software tools to design, analyze, and test medical devices.

A master’s degree in biomedical or reliability engineering or a related discipline can provide more in-depth knowledge and can be beneficial for those looking to advance in their career.

Courses in quality management, statistics, reliability analysis, and risk management can be particularly useful for this role.

Certain positions may require Medical Devices Reliability Engineers to have a Professional Engineer (PE) license, which involves passing two exams and gaining professional experience.

Certifications in reliability engineering, quality engineering, or medical device engineering, such as those offered by the American Society for Quality (ASQ), can be beneficial.

These certifications indicate a commitment to the field and an understanding of industry standards and regulations.

Continuing education is crucial in this role due to the rapid technological advancements in the field of medical devices.

Therefore, attending workshops, seminars, and training programs to stay updated with the latest technologies and regulatory requirements is highly recommended.

In addition to education, a Medical Devices Reliability Engineer needs to have excellent analytical, problem-solving, and communication skills.

They also need to have an understanding of medical regulations and standards, such as FDA regulations and ISO standards for medical devices.

 

Medical Devices Reliability Engineer Salary Expectations

The average salary for a Medical Devices Reliability Engineer is $92,133 (USD) per year.

The actual salary may vary depending on factors such as experience, education, the size and location of the company, and the complexity of the medical devices they work with.

 

Medical Devices Reliability Engineer Job Description FAQs

What skills does a Medical Devices Reliability Engineer need?

Medical Devices Reliability Engineers need a good understanding of engineering concepts and principles, especially as they apply to the design and function of medical devices.

They should have strong analytical and problem-solving skills to identify and address issues in device reliability.

Communication skills are also important, as they need to document their findings and work with interdisciplinary teams.

Familiarity with statistical analysis and medical device regulations is also beneficial.

 

Do Medical Devices Reliability Engineers need a degree?

Yes, a degree in an engineering field such as Biomedical Engineering, Mechanical Engineering, or Electrical Engineering is typically required for this role.

Some positions may require a master’s degree or other advanced training in a related field.

Knowledge and understanding of medical device regulations and standards, such as those set by the FDA, are also crucial.

 

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

Look for a solid educational background in a relevant engineering field and any advanced degrees or certifications.

Experience in the medical device industry, especially with reliability testing, is a major plus.

You should also look for experience with statistical analysis software, as this is often used to evaluate device reliability.

Familiarity with regulatory standards and protocols for medical devices is also important.

 

What qualities make a good Medical Devices Reliability Engineer?

A good Medical Devices Reliability Engineer is meticulous and detail-oriented, ensuring all aspects of a device’s design and function are thoroughly tested for reliability.

They should have strong analytical skills to identify potential issues and develop solutions.

Good communication skills are also necessary, as they will need to collaborate with various teams and report their findings.

They should also be committed to staying updated on the latest medical device regulations and standards.

 

What is the importance of a Medical Devices Reliability Engineer in the healthcare industry?

Medical Devices Reliability Engineers play a crucial role in ensuring the safety and efficiency of medical devices.

By performing reliability testing and analysis, they help to reduce device failures and improve patient outcomes.

Their work helps to increase trust in medical devices and contributes to the overall quality of healthcare services.

 

Conclusion

And there you have it.

Today, we’ve shed some light on what it truly means to be a Medical Devices Reliability Engineer.

And you know what?

It’s not just about maintaining equipment.

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

With our comprehensive Medical Devices Reliability Engineer job description template and real-world examples, you’re equipped to take your next step.

But why limit yourself?

Delve deeper with our job description generator. It’s your key to producing precision-crafted listings or fine-tuning your resume to absolute excellence.

Remember:

Every medical device is a part of the bigger picture.

Let’s build that healthier future. Together.

How to Become a Medical Devices Reliability Engineer (Complete Guide)

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