Medical Device Systems Engineer

A medical device systems engineer is responsible for the design, integration, and management of complex medical systems over their complete life cycles.

What is a Medical Device Systems Engineer?

A medical device systems engineer is responsible for the systems engineering of medical devices.

Systems engineering is an interdisciplinary field of engineering that generally focuses on the design, integration, and management of complex, interconnected systems over their complete life cycles. Systems engineering covers design, realization, technical management, operations, and retirement of a system and incorporates hardware, software, equipment, facilities, personnel, processes, and procedures.

Apart from handling most of the technical aspects regarding a system, systems engineers may also interact with customers and suppliers to align on planning, progress, and transfer of results.

The exact role and responsibility of a systems engineer on a medical device may change depending on the size and complexity of the device and the specific phase of the life cycle.

The systems engineer also is also typically responsible for documenting the stakeholder expectations, requirements, architecture and design, and verification and validation procedures.

A systems engineer must be able to look at the “big picture” to ensure that they develop the right design, which means one that satisfies the requirements, enables operational goals and meets stakeholder expectations.

A systems engineer must be able to optimize the design and not favour one sub-system at the cost of another while constantly validating that the goals of the overall system will be met.

What does a medical device systems engineer do?

The duties of a medical device systems engineer include, but are not limited to the following:

  • Collect stakeholder input and translate into design requirements to positively impact stakeholder experience.
  • Engage with external stakeholders (clinicians, researchers, and customers) to uncover insights and turn application requirements into clear technical specifications.
  • Focus on patient experience, clinician adoption, quality, reliability, and manufacturing.
  • Deliver system designs that comply with medical device regulations.
  • Manage development with external partners including communicating technical level details.
  • Plan and execute testing of prototypes, pre-production, or finished products to verify design requirements are met.
  • Support clinical validation activities, engage with external parties to conduct clinical studies, oversee data collection, and ensure physiologically relevant data analysis and interpretation.
  • Document the design, development and testing activities in compliance with medical device regulations.
  • Provide clear updates on project status, technical risk, and factors that impact success.

How do I become a medical device systems engineer?

Since medical device systems engineering is a multi-disciplinary engineering field, it is best if you have a Bachelor’s Degree in an Engineering discipline like electrical engineering, software engineering, mechanical engineering, or biomedical engineering.

Additionally, a systems engineer needs:

  • To be able to manage projects
  • To be familiar with the typical medical system development processes
  • Experience in clinical testing and validation of medical technologies
  • To be familiar with medical device standards
  • Strong presentation and technical documentation skills.

There are a variety of university programs in systems engineering. Alternatively, if you have some engineering training, but would like to specialise in medical device systems engineering, you may be able to join a medical device engineering company, e.g. ArrowFast or Cosylab, and get on-the-job training. In this way, you will be able to learn while actually designing and integrating medical systems.

Are you interested in a career in medical device systems engineering? Check out the Cosylab careers page for open positions.