UNEEG medical - an innovative medical device company – is looking to recruit a Systems Engineer to join our team in Allerød. UNEEG is on a path to change the treatment of epileptics by ultra-long term monitoring, and you now have the chance to be part of that journey.
As a Systems Engineer you will have a leading role in our design and development projects, where you will contribute with creating product documentation such as design input/output, design verification plans and tests as well as risk management files. Furthermore, you will be the technical systems lead and thereby ensuring that the product solution fulfils the customer need – seen from a technical perspective. You are highly motivated by working in project teams and finding the good and pragmatic solutions to technical problems and documentation challenges. You take pleasure in supporting and communicating to internal stakeholders how to adequately use the design control principles in product development. You are familiar with the whole lifecycle for medical devices, and you understand how the technical documentation is built. It is expected that you over time will be the Systems Engineering go-to-person on our EEG measuring solution, which means that you will also take part in product sustaining projects and design changes.
You will be part of a team consisting of five Systems Engineers with various levels of experience. It is expected that you will be a key person in the team driving decisions and development within Systems Engineering. You will be working closely with internal stakeholders, such as regulatory affairs, software/hardware engineers, project managers and clinical affairs. Your mindset is pragmatic, holistic, quality oriented and preferably with a high level of process structure.
- Master’s or bachelor’s degree in engineering or related
- Extensive knowledge of ISO 13485, Medical Device Regulation 2017/45 and FDA 21 CFR part 820
- Experience with systems engineering on medical devices comprising hard-ware and software
- Experience with risk management per ISO 14971:2019
- Experience with conducting design validation and knowledge of the principles in usability per EN 62366 and FDA’s guidance on Human Factors Engineering is an advantage
- You are a team player
- You have good communication skills
- You have an analytical and structured approach to your work, but at the same time, you are open-minded and see possibilities
- You are proactive, good at prioritizing, planning, and finalizing your tasks
For further information do reach out to Line Hassenkam Pedersen, firstname.lastname@example.org
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