Roles for a Biomedical Engineer

If you're a recent graduate, or someone who is thinking about studying Biomedical engineering, this article will help you understand the different roles that are available in the market for alumni of programs in Biomedical engineering.

In a nutshell, a B.Sc in Biomedical engineering combines the basic principles of engineering and basic concepts in human anatomy and physiology with a focus on one classic engineering discipline such as mechanical engineering, electrical engineering or computer science. The focus depends on the student's preference and on the available specializations offered by the institution.

What is the biomed-tech industry? Companies that are operating within this market offer solutions to medical problems. These include medical devices, biomaterials and tissue engineering solutions, software platforms for healthcare providers and bioinformatics research. The industry is very varied and every niche requires it's own set of specialized skills, as a Biomedical Engineering graduate you will have basic knowledge in all of the mentioned categories but for some roles you'll need to prove specialized skills.

1) Roles that are more widely available for Biomedical Engineers:

The listed roles here are roles that can usually be found in every niche in the biomed-tech industry and will require little to no additional education for a biomedical engineer to get hired. These roles require wider knowledge across many disciplines but don't require a specific specialization in most cases, which allows recent graduates to integrate more naturally into them.

• Application Engineer: An application engineer in the biomed-tech industry is a technical professional responsible for designing and implementing solutions for medical technology products and services. They work closely with sales teams, customer service representatives, and product development teams to identify customer needs, design custom solutions, and implement them. They provide technical support to customers during and after the implementation of medical technology products and services. They must have a deep understanding of the technology, including hardware, software, and networking, as well as knowledge of relevant regulations and standards. Entry level positions are available. Development options: Team leader, product manager.
• Verification and Validation (V&V) Engineer: A V&V engineer in the biomed-tech industry is a technical professional responsible for ensuring that medical technology products and services meet regulatory requirements and industry standards. They develop and execute testing plans to verify and validate the functionality, performance, and safety of the products and services. They work closely with cross-functional teams, including product development, quality assurance, and regulatory affairs teams, to identify testing requirements and ensure compliance with applicable regulations. They must have a deep understanding of the technology and regulatory requirements, as well as knowledge of industry standards such as ISO 13485 and FDA regulations. They play a critical role in the success of medical technology products and services by ensuring that they are safe, effective, and compliant with regulatory requirements and industry standards.

-Entry level positions are available

-Development to other departments: System, R&D

• System Engineer: A system engineer in the biomed-tech industry is a technical professional responsible for designing, developing, and maintaining complex medical technology systems. They work closely with cross-functional teams, including product development, software engineering, hardware engineering, and regulatory affairs, to define system requirements and ensure that the system meets the needs of customers and regulatory requirements. They must have a deep understanding of the technology, including hardware and software design principles, as well as knowledge of regulatory requirements and industry standards. They play a critical role in the success of medical technology products and services by ensuring that they are designed, developed, and deployed to meet the needs of customers effectively, and comply with regulatory requirements and industry standards. This role usually requires at least 3 years of experience in the industry, usually from V&V or R&D departments.

-At least 3 years of experience from R&D, V&V departments are usually required

-Development to other departments: R&D

• Regulatory Quality Assurance (QA) Engineer: A regulatory QA engineer in the biomed-tech industry is a technical professional who works closely with cross-functional teams, including product management, regulatory affairs, and R&D, to develop and execute quality plans and ensure that products meet regulatory requirements throughout the product lifecycle. They are responsible for reviewing product documentation and processes, conducting risk assessments, and managing product complaints and recalls. They must have a deep understanding of applicable regulations and standards, including FDA regulations and ISO standards, and be able to apply that knowledge to ensure compliance.

-Entry level positions are available

-Development to other departments: RA

• Regulation Affairs (RA) Engineer: A Regulatory Affairs engineer in the biomed-tech industry is a technical professional responsible for ensuring that medical technology products and services meet regulatory requirements in the markets they are intended for. They work closely with cross-functional teams, including product development, quality assurance, and legal, to develop and implement regulatory strategies for medical technology products and services. They are responsible for obtaining and maintaining regulatory approvals and clearances from regulatory bodies, such as the FDA or CE Mark in Europe, by preparing and submitting appropriate documentation and responding to regulatory inquiries. They must have a deep understanding of the regulatory requirements for medical technology products and services, including pre-market submissions, post-market surveillance, and adverse event reporting. They play a critical role in the success of medical technology products and services by ensuring that they comply with regulatory requirements, are safe and effective for their intended use, and can be marketed and sold in the markets they are intended for.

-Entry level positions are available but a course in medical device regulation can be a big advantage.

2) Roles that are harder to get into and will require you to use leverage of a chosen specialization and/or additional learning through courses:

• Data Analyst: A data analyst in the biomed-tech industry is a technical professional responsible for analyzing and interpreting data related to medical technology products and services. They work closely with cross-functional teams, including product development, sales, marketing, and research and development, to identify and analyze relevant data sets to inform business decisions. They are responsible for designing and implementing data collection and analysis methodologies, as well as developing and maintaining data management systems. They play a critical role in the success of medical technology products and services by providing insights that inform product design, development, and commercialization strategies, and helping to ensure that medical technology products and services meet customer needs and regulatory requirements.

- Additional requirements: Computer Science or Data science specialization during bachelor's degree with a well presented portfolio of projects that demonstrate the following skills: SQL, Python, Data visualization, Statistical analysis methods, MongoDB, Pyspark.

• Product Manager: A product manager in the biomed-tech industry is a business professional responsible for overseeing the development and management of medical technology products and services. They work closely with cross-functional teams, including engineering, marketing, sales, and regulatory affairs, to define product strategy, roadmap, and development priorities. They are responsible for identifying customer needs and market opportunities, conducting market research, and defining product requirements. They must have a deep understanding of the technology, market trends, and competitive landscape, as well as knowledge of regulatory requirements and industry standards. They play a critical role in the success of medical technology products and services by ensuring that they meet customer needs, are commercially successful, and comply with regulatory requirements and industry standards.

- Additional requirements: A Product Management course, 3+ years of experience as an application engineer or experience in management of technical teams (R&D engineers, application engineers, software developers), or an M.Sc in engineering or management.

• Research and Development (R&D) Engineer: An R&D engineer in the biomed-tech industry is a technical professional responsible for designing, developing, and testing new medical technology products and services. They work closely with cross-functional teams, including product management, quality assurance, regulatory affairs, and clinical research, to define product requirements and develop product designs that meet customer needs and regulatory requirements. They are responsible for conducting research, designing and prototyping products, and testing and validating product designs. They must have a deep understanding of the technology, including relevant scientific and engineering principles, and be able to apply that knowledge to solve complex problems and develop innovative solutions. They play a critical role in the success of medical technology products and services by ensuring that they meet customer needs, are safe and effective for their intended use, and can be brought to market efficiently and effectively.

- Additional requirements: Specialization during bachelor's degree in the sphere you wish to design in. It can be in electronics, mechanics, materials. It is crucial as a biomedical engineer to prepare a portfolio of projects displaying the relevant skills which could be: board design, design in Solidworks, research in material science.

3) Roles that mostly require an M.Sc degree or higher:

• Data Scientist: A data scientist in the biomed-tech industry is a technical professional responsible for analyzing complex data sets related to medical technology products and services. They work closely with cross-functional teams, including product development, research and development, clinical research, and regulatory affairs, to identify patterns and trends in data that can inform business decisions. They are responsible for designing and implementing data collection and analysis methodologies, developing and maintaining data management systems, and using advanced techniques and models to develop predictive and prescriptive models that inform future decisions. They must have a deep understanding of the technology, statistical analysis methods, machine learning algorithms, and relevant regulatory requirements.

- Relevant M.Sc programs: Mathematics, Statistics, Data Science, Electrical/Biomedical engineering with relevant research.

• Algorithm Developer: An algorithm developer in the biomed-tech industry is a technical professional responsible for designing and developing algorithms that are used in medical technology products and services. They work closely with cross-functional teams, including software development, data science, and product management, to understand customer needs and develop algorithmic solutions that meet those needs. They are responsible for researching and implementing mathematical models, statistical analysis methods, and machine learning algorithms that can be applied to medical data sets. They must have a deep understanding of the technology, mathematical modeling, statistical analysis methods, and relevant regulatory requirements. They play a critical role in the success of medical technology products and services by providing innovative algorithms that enable the analysis of medical data and the development of intelligent medical technology products and services.

- Relevant M.Sc programs: Mathematics, Statistics, Electrical/Bio-medical/Mechanical engineering with relevant research.

• Senior R&D Engineer: A senior R&D engineer in the biomed-tech industry is an experienced technical professional responsible for leading the design, development, and testing of new medical technology products and services. They work closely with cross-functional teams, including product management, quality assurance, regulatory affairs, and clinical research, to define product requirements and develop product designs that meet customer needs and regulatory requirements. They are responsible for leading research efforts, designing and prototyping products, and testing and validating product designs, as well as mentoring and leading junior engineers in the development process. They must have a deep understanding of the technology, including relevant scientific and engineering principles, and be able to apply that knowledge to solve complex problems and develop innovative solutions. They play a critical role in the success of medical technology products and services by ensuring that they meet customer needs, are safe and effective for their intended use, and can be brought to market efficiently and effectively, while mentoring and leading junior engineers in the development process.

- Relevant M.Sc programs: Electrical/Mechanical/Materials Engineering programs.

All mentioned roles above have development options to seniority, as well as specialized roles within their native departments and management.

Summary:

The advantage of a Biomedical engineering degree is that it provides comprehensive knowledge in multiple engineering and life-sciences disciplines. It is a great time studying in a program like this (at least it was for me and my friends) but there are disadvantages that must be considered. The disadvantage is that you're not a specialist in any of the disciplines, and a lot of sought-after positions in the industry require a specialization and a certain skill-set. Thus, if you are a biomedical engineer who wants to work in one of the roles that require additional education keep this in mind and make sure you know how to leverage yourself.

Naive Fascination: Biomedical engineering has the ability to model physiological systems of the human body in the language of electrical circuits, mechanical components and mathematical differential equations. This is truly fascinating because it allows to see how different parts of the physiological system react to changes in the system. The Windkessel model[2] is one example:

Credits:

[1] The heart image:

Image by brgfx on Freepik

[2] The windkessel model https://www.civilized.com/mlabexamples/windkesmodel.htmld/

[3] The bionic prostheses cover image

Image by macrovector on Freepik