Medical Devices Tester Job Description [Updated for 2025]

In the evolving landscape of healthcare technology, the role of medical devices testers has become increasingly pivotal.

As medical science continues to advance, so does the urgency for proficient individuals who can thoroughly assess, ensure quality, and guarantee the safety of our medical devices.

But let’s delve deeper: What’s really required of a medical devices tester?

Whether you are:

• A job seeker trying to understand the core of this role,
• A hiring manager outlining the perfect candidate,
• Or simply captivated by the inner workings of medical device testing,

You’ve landed in the right place.

Today, we present a customizable medical devices tester job description template, crafted for easy posting on job boards or career sites.

Let’s dive right in.

Medical Devices Tester Duties and Responsibilities

Medical Devices Testers play a critical role in ensuring that medical devices function correctly and are safe to use in medical and healthcare environments.

They use their technical knowledge and attention to detail to thoroughly test devices and identify any potential issues.

They have the following duties and responsibilities:

• Conduct thorough testing on various medical devices to assess their functionality and safety
• Analyze and interpret test data and results
• Prepare detailed test plans and test cases based on device specifications
• Document test procedures, observations, final test results, and data for regulatory submissions
• Identify, log, track, and verify resolution of software and specification defects
• Work closely with design and production teams to understand the device functionality and testing needs
• Use specialized testing tools and equipment as required
• Conduct root cause analysis for defects and recommend corrective actions
• Ensure testing procedures comply with industry and regulatory standards
• Maintain up-to-date knowledge of medical device testing trends and advancements

 

Medical Devices Tester Job Description Template

Job Brief

We are seeking a meticulous and highly analytical Medical Devices Tester to join our dynamic team.

The successful candidate will be responsible for conducting rigorous tests on various medical devices, ensuring they meet regulatory standards and are safe for use.

Medical Devices Tester responsibilities include creating test plans, conducting functional and non-functional tests, documenting findings, and suggesting improvements.

The ideal candidates should be well-versed in all stages of the testing process and able to ensure every medical device is thoroughly tested before it is released to the market.

 

Responsibilities

• Create detailed test plans and strategies
• Conduct functional and non-functional tests on medical devices
• Record testing processes and document results
• Identify and communicate any product issues or defects
• Suggest improvements to optimize performance
• Ensure all devices meet regulatory standards and safety guidelines
• Collaborate with the development team to plan for new product testing
• Prepare reports on findings and communicate the same to the management

 

Qualifications

• Proven experience as a Medical Devices Tester or similar role in the Healthcare Industry
• Knowledge of medical device regulations and standards
• Experience in quality assurance and product testing
• Strong analytical and problem-solving skills
• Excellent attention to detail
• Ability to write clear and concise technical reports
• BSc degree in Biomedical Engineering or related field

 

Benefits

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

 

Additional Information

• Job Title: Medical Devices Tester
• Work Environment: Lab setting with occasional office work. Some travel may be required for training or industry events.
• Reporting Structure: Reports to the Quality Assurance Manager or Product Development Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $75,000 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 Tester Do?

Medical Devices Testers typically work for medical equipment manufacturers, pharmaceutical companies, and regulatory agencies.

They may also work as freelance consultants.

These professionals primarily focus on ensuring the safety and efficacy of medical devices.

Their tasks often include conducting tests on various medical devices like pacemakers, ventilators, MRI machines, and surgical instruments to name a few.

Their job involves developing and implementing test procedures for devices, collecting and analyzing data from these tests, identifying any issues or malfunctions, and creating comprehensive test reports.

They may also be involved in the initial design stages of new devices, providing valuable insight into potential design flaws or areas for improvement.

They ensure that devices meet all necessary specifications and comply with regulatory standards.

Medical Devices Testers also collaborate with other professionals like biomedical engineers and quality assurance teams to ensure the devices are safe and effective for use.

Additionally, they may help in troubleshooting, fixing, and calibrating devices, as well as updating the software of computer-based medical equipment.

Their ultimate aim is to ensure that medical devices function as intended without posing any risk to patients or medical professionals.

 

Medical Devices Tester Qualifications and Skills

A Medical Devices Tester must possess a variety of specialized technical skills, soft skills, and a deep understanding of medical devices and their operation, such as:

• Technical knowledge of medical devices and their operation, to effectively test and troubleshoot any problems that may arise.
• Analytical thinking skills to determine and assess the function and operation of the device, and to establish testing procedures.
• Exceptional attention to detail to ensure that all devices are tested thoroughly and that no faults are overlooked.
• Strong communication skills to accurately document test results, report any issues to the necessary parties, and to work effectively within a team.
• Ability to work independently and manage multiple tests simultaneously, maintaining organization and efficiency.
• Problem-solving skills to quickly identify and resolve issues that may occur during the testing process.
• Knowledge of regulatory standards and compliance requirements for medical devices to ensure all devices meet these standards.
• Proficiency in using various software and tools used in the testing process, as well as a willingness to learn new technologies as needed.

 

Medical Devices Tester Experience Requirements

Medical Devices Tester positions often require at least a bachelor’s degree in a science-related field, such as biology, medical technology, engineering, or a similar discipline.

Entry-level Medical Devices Testers might have 1 to 2 years of experience, often gained through internships or part-time roles in a medical, scientific, or engineering laboratory.

They may have also gained experience in roles such as Quality Assurance Associate, Laboratory Technician, or related roles in the medical device industry.

Candidates with 3 to 5 years of experience often have developed their practical skills and technical knowledge in entry-level Medical Devices Tester roles.

They may have contributed to the testing of a variety of medical devices, participated in quality assurance processes, and contributed to product development processes.

Those with more than 5 years of experience may have leadership experience, such as supervising a team of testers, coordinating testing processes, and liaising with regulatory bodies.

At this level, they may be ready for a managerial or team-lead position within the medical device testing field.

In addition to these technical requirements, Medical Devices Testers often need a good understanding of regulations and standards in the medical device industry, such as those set by the FDA or other regulatory bodies.

They also need excellent attention to detail, analytical skills, and the ability to work in a highly regulated environment.

 

Medical Devices Tester Education and Training Requirements

Medical Devices Testers typically have a bachelor’s degree in biomedical engineering, electrical engineering, or another related field.

Along with their degree, testers should have a solid understanding of medical device regulations, quality control methods and standards such as ISO 13485 and FDA Quality System Regulations.

In addition to this, knowledge of various testing methods and tools, data analysis, and problem-solving skills are crucial for the role.

Some positions, especially those involved in the testing of complex medical devices, may require individuals to have a master’s degree in biomedical or electrical engineering, or in a specialized field of medicine that correlates with the device they will be testing.

It is also beneficial for Medical Devices Testers to have relevant industry certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).

These certifications not only validate a tester’s knowledge and skills, but also demonstrate their commitment to the profession and ongoing learning.

On-the-job training is a critical component of a Medical Devices Tester’s education, as it provides practical experience with the specific devices and testing protocols they will encounter in their work.

 

Medical Devices Tester Salary Expectations

A Medical Devices Tester can expect to earn an average salary of $68,789 (USD) per year.

The actual earnings can significantly vary based on factors such as years of experience, the complexity of the devices tested, geographical location, and the company that the tester works for.

 

Medical Devices Tester Job Description FAQs

What skills does a Medical Devices Tester need?

A Medical Devices Tester should have a keen eye for detail to spot any faults or issues with the devices.

They should have good problem-solving skills to determine the causes of faults and how to fix them.

Knowledge of electronics and engineering is also important.

Additionally, they should have the ability to work under pressure and meet strict deadlines, as well as the ability to communicate effectively to relay important information about the devices.

 

Do Medical Devices Testers need a degree?

Yes, typically a Medical Devices Tester will need a degree in a related field such as biomedical engineering, electronics or a related scientific field.

Some employers may also prefer candidates who have previous experience in the field of medical device testing or quality assurance.

 

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

A Medical Devices Tester resume should highlight a solid educational background in a related field, as well as any relevant work experience.

It should also detail specific testing procedures the candidate is familiar with, and any certifications they may hold.

Any experience with specific types of devices, as well as familiarity with regulatory standards and guidelines, would also be beneficial.

 

What qualities make a good Medical Devices Tester?

A good Medical Devices Tester is meticulous and detail-oriented, ensuring that all devices are tested thoroughly and meet the highest standards of quality and safety.

They should be able to work independently and make critical decisions.

Good problem-solving skills are also essential, as they will need to identify and troubleshoot any issues or faults with the devices.

 

What is the typical career progression for a Medical Devices Tester?

Medical Devices Testers can advance their careers in several ways.

With additional education and experience, they can move into higher-level positions such as Senior Tester or Testing Manager.

They may also transition into roles in Quality Assurance or Regulatory Affairs, focusing on ensuring that devices meet all necessary regulations and standards.

Some may choose to specialize further in a specific type of device or testing procedure.

 

Conclusion

And there you have it.

Today, we’ve delved into the intricate world of a Medical Devices Tester.

Surprised?

It’s not just about routine testing.

It’s about ensuring the safety and efficacy of medical devices, one device at a time.

Armed with our comprehensive Medical Devices Tester job description template and hands-on examples, you’re ready to take the leap.

But why stop there?

Immerse yourself further with our job description generator. It’s your next step to creating detailed job listings or refining your resume to sheer perfection.

Remember:

Every device tested is a contribution to healthcare safety.

Let’s build a safer future. Together.

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