Original Beschreibung
Job Description
Systems Engineer
City:
Ballerup, Denmark; Augsburg, Germany
State:
Country:
Germany
Business Area:
R&D
Department:
Systems Engineering, Engineering & Imaging
Employment Type:
Full-time
Do you have experience in developing medical devices? Would you like to be a part of developing innovative new products that have a significant impact on patient lives, and to apply your skills in a global MedTech company currently disrupting the endoscopy market?
Then your next career move may be as an Systems Engineer with Ambu!
**Be a key player in Engineering and Imaging**
In this exciting position, you will be an active contributor within the R&D organisation, and a leading member of a product development project. You will take a key role in developing our new, exciting endoscopy products and secure the future success of Ambu as well as to the benefit for our users. You will become part of a dynamic, professional, and global team, working on projects at both our headquarters in Ballerup Denmark, as well as our development site in Augsburg, Germany. We have a great innovation culture and a clear focus on fast time to market, and we are dedicated to developing the right product to fulfill customer/user needs and positively impact patients’ lives. This sets high demands to your understanding of developing medical devices and their integration into complex systems.
You will be joining a global Systems Engineering team consisting of 17 ambitious and dedicated members, located at multiple sites, and will be part of Engineering & Imaging, within the R&D organisation. The team is divers, highly skilled and has many years of experience and expertise in developing the unique products that Ambu has on the market.
**Global, user-driven innovation – from idea to launch**
As a Systems Engineer you will work together with other members of the systems engineering team to hold the overall high level technical view and help the subject matter experts, team members and relevant stakeholders understand each other and collaborate together. You will assist the Lead Systems Engineer/Technical Lead in larger complex new development projects, or work as the systems engineer/technical lead in smaller line extension projects, working and supporting on activities such as driving and owning the technical solution, and making decisions on compromises when needed. Further, you will help create, facilitate, and review product documentation such as requirements, design inputs, design outputs and technical reviews.
You enjoy working in project teams and can identify pragmatic solutions to technical issues along with promoting the right level of documentation towards stakeholders. You will be involved all phases of product development process – from the initial scope investigation, through conceptual design to the product validation and all the way to market launch.
You will be part of the global Systems Engineering team, and report to the Systems Engineering Team Manager. This position will be based out of Augsburg, however, applicants for Ballerup Denmark will be considered.
**Your Responsibilities**
* To support, define, plan, document and technically manage product development activities within a new development project, to ensure that the product is delivered in accordance with the defined project design objectives and design and development plan.
* Identification and understanding of User Needs through engagement with key stakeholders.
* Analyse and decompose the User Needs, Business Needs, and System Requirements into product requirements, including design control and development requirements.
* To assist with building and leading the technical team in coordination with the Lead Systems Engineer, Project Manager and Line Managers.
* Follow, align, and reuse product architecture and design solutions within the R&D organisation.
* Investigate, scope and development of new products within existing or new clinical areas for Ambu based on our technology and capabilities.
* Establishing and maintaining the technical overview incl. interfaces and compromise between technologies.
* Working, documenting, and testing according to FDA and ISO requirements.
Your contact base is broad, and you will collaborate with Ambu’s global organization, all departments involved in product development projects and externally with users, knowledge centres, technical partners, and suppliers. Our production sites are in Malaysia, China, USA and Mexico and we work together with KOL’s and development centres throughout Europe and the US, so some travel is to be expected with this position.
**Suggested candidate profile**
Setting you up for success is one of our cornerstones. In order to do so, we imagine, you as a person are pro-active, with high drive, commitment and have a strong sense of responsibility for your own tasks. You are thorough and quality-minded; you have great interpersonal skills and have a good situational awareness making you a great team-player in global teams.
Skills and experiences can be gained in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have:
* An educational background within mechanical engineering, electrical engineering or similar.
* Experience in developing medical devices and have a thorough understanding of design control, including working with requirements in a medical setting, or another regulated industry.
* Experience as a senior/lead design engineer, project engineer or similar, with a minimum of 5 years industry experience within product development. Experience as a technical lead within a project would be an advantage.
* A strong systems engineering mindset as well as a mechanical mindset where “things right the first time” and making robust designs are important for you.
* Experience in product development, plastic and mechanical design especially for single-use products or electro mechanical display devices would be an advantage. Most likely, you come from a similar job within the medical device industry or in a consultancy that deals with the medical device field.
* Work independently and take responsibility for your own tasks, and you have a pragmatic and practical approach to assignments. You actively support knowledge sharing and exploitation of best practice and you enjoy being part of a global team.
As Ambu is a global company, it is important that you communicate fluently in English. Only applications recieved in English will be considered.