Obtaining a degree in biomedical engineering opens several doors for young professionals. It can be a daunting experience looking for new jobs with limited industry experience, as the day-to-day tasks of individual engineers can vary wildly. This article will provide you with a brief overview of some of the tasks that different biomedical engineers complete within industry.
Manufacturing Engineer
Manufacturing engineers work on existing product lines and help oversee the day-to-day performance of these processes. It is heavily output driven with the focus being on ensuring everything runs smoothly to allow the company to fulfil its orders in a timely manner. They would be responsible for the continuous improvement aspect of manufacture by examining the slowest process steps or ones where fallout is highest and performing improvement activities such as introducing better equipment, extra operators/machines or adjusting processing aids to reduce fallout and provide cost savings.
Manufacturing engineers may also be required to work under pressure such as in line down situations where equipment fails in use and requires repair. In these situations, time is critical as a line down situation could be costly to the company. However, this should be a rare event and for the most part they should be just working to help monitor production and overseeing the lines to ensure that targets are hit.
Process development engineers who are bringing new processes into the production environment may consult with manufacturing. Depending on the company size there may be a lot of input by manufacturing engineers at this stage into how to adequately scale the process and ensure it will work in a full production setting. It would be quite common that there is an overlap period on product transfers where process and manufacturing work in tandem to ensure a smooth transition.
As manufacturing engineers work on commercial product, they work closely with quality engineering also. Manufacturing engineers would be very well versed in Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) which are critical for maintaining high standards of production quality, as well as ensuring that the required levels of traceability are present in the event of an audit or recall situation.
Who is suited: Someone who loves the idea of continuous improvement and the idea of implementing small improvements to see big results. People who like on the fly problem solving would also be a good fit.
Who may not be as suited: People who are very keen to work on the development side of Medtech, and desire a fast-paced project.
Process Development Engineer
Process development engineers operate as the in between point between R&D and manufacturing as a company works on improving, qualifying, and transferring new processes. They can have a quiet diverse set of responsibilities, again, depending on what size company they are working in. Once the R&D phase is concluded the company’s next focus turns to introducing the project to full scale production, and this can mean tight timelines. The upside of this, however, is it provides a great opportunity to learn, and these new processes can be very satisfying to initially scale up and trouble shoot. The role also offers a lot of interaction and teamwork with other departments and people such as operators, R&D, manufacturing, quality and even outside vendors.
From a “hands on” technical standpoint, they may be involved in the initial scaling up of processes, bringing in operators for training, identifying equipment requirements for new processes, performing timing studies to ensure that demand can be met with the particular production line, root causing various issues within the process as it is initially being scaled and then dealing with the inevitable teething problems that comes with transfers. It is generally a very interesting area to work within as the process development engineer gets to work hand in hand with the R&D engineers in developing future devices. Statistical analysis techniques are commonly used to gain insights into how well a process is performing and ensure it can meet demand at scale. Process improvement activities are carried out to help increase Key Performance Indicators (KPI’s) before a project is handed over to manufacturing. Before implementing any improvement activities, the engineers demonstrate that there is minimal risk to introducing the change and that there is a noticeable benefit for the company (cost saving, time saving, yield improvement, product quality).
From the documentation standpoint, they would be involved in pFMEA documentation, release of procedures for how the device is made and the completion of different validation activities as it transfers over to manufacturing. If the product utilises some outside material vendors for manufacturing sub-components, they may be involved with site visits to their vendor and ensuring that they are adequately set up to meet their demand. They may also be involved with the validation activities at the vendor and ensuring everything is completed on schedule and to a high standard.
Who is suited: People who like to implement changes quickly and see fast results. Quick thinkers who are very hands on and not afraid to get stuck into problems to find a great solution. Someone who enjoys an array of tasks and collaboration between different teams from R&D, quality, and manufacturing.
Who may not be suited: People who desire and work best in a regimented environment with clearly defined goals and less aggressive timelines.
Quality Engineers
Quality engineers work across most project stages but are generally not involved with the early R&D work. The most important role of quality is ensuring that the other engineers, and the other company functions, comply with the Quality Management System (QMS) that is in place. To state the obvious – they are responsible for quality.
In smaller companies, the role of quality engineers is diverse, and they get exposure to a large amount of the different aspects that make up the QMS. For example, they may be responsible for qualifying and assessing new vendors for the company, while also working on issues with non-conformances within their own companies manufacturing department and reviewing new procedures, reports and protocols etc. This amount of exposure would be less in a larger company typically, where you see more types of quality engineers that are more specialised. A good example is supplier quality. As large companies deal with several different vendors, it is in their best interest to employ quality engineers solely focussed on this aspect of quality engineering. This ensures a smoother operation of the company.
At the end of the day, all engineering boils down to problem solving. Quality engineering is no different, although the problems faced don’t really align with what you would expect. For example, they may be responsible for helping to develop rationales for the use of equivalent materials/ machines. Or perhaps they identify time consuming steps within the QMS and work to resolve them to make the lives of other engineers easier – like streamlining a commonly used form or developing an easier system to approve new vendors.
Who is suited: Someone with an attention to detail and think they would enjoy working within the QMS system and helping to improve and refine it.
Who may not be suited: Someone who loves hands on work and is not keen on the focus of documentation.
R&D Engineer
R&D engineers focus on the early stages of projects and handle the design of the device itself. As above, there can be a lot of variability in what exact tasks are required depending on the project stage. Early on in projects R&D engineers may be performing literature reviews and meeting with leading clinicians in their devices therapy area to determine what are the main needs for the project and how big of a market would be available to them.
Following the early project work, the engineers would begin to narrow down on the exact device requirements needed to meet the demands of the therapy area. The next stage would be prototyping design concepts and testing them in labs. The testing can consist of simple tensile/ compression tests but may also include purpose-built bench top test fixtures that are made to represent use conditions. Animal trials and possible cadaver trials can also form part of this phase as the R&D engineers will focus on gaining as much information as possible about their device. Throughout this entire development process clinician feedback will always be an important input into any new iterations that the engineers make as they will be the end user when in surgery.
As the R&D engineers iterate, they begin to come closer to their final design. A large amount of documentation work must be prepared to accompany this final design detailing how the team got from its initial starting point to their current final design. This would include risk documentation such as dFMEA’s where all the design inputs (design inputs are what you require your design to do e.g., deploy a stent, reach the target location, resist deformation during advancement etc.) are outlined as well as the possible failure modes and associated risk. There would also be in depth biocompatibility assessments completed to ensure that all materials used are safe for use in humans.
When the design is finally frozen, a large amount of testing takes place to test the functionality of the device against pre-determined specifications. This suite of testing leads up to a clinical trial where patients are treated with the new device and the outcomes analysed to ensure positive results and gather data to present to regulators. Finally, following a successful clinical trial, the device receives approval for full commercial launch.
Who is suited: Someone who is interested in both the engineering and biological side of medical device design. Somebody who is hands on and can develop novel solutions to complex problems.
Who may not be suited: Someone that prefers small regular wins on projects. R&D can be difficult at times as the solutions can take a long time to find. Someone who has little interest about the anatomy and actual treatment side of the device may also be better working in a process role, where more time is spent utilising engineering principles and tools.
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