Engineer with interest in Technical Documenation

Join a growing company with a strong purpose

Do you want to make a difference for people breathing, speaking and living with a neck stoma?

The R&D Team focusing on new product development at Atos Medical is now looking for a new colleague with interest in Technical Documentation. Are you a engineer passionate about teamwork and value creation? Are you ready to play a key role bringing new Innovations to market? If you join you will be able to make a difference by everyday work.



About the role

At Atos Medical, we are passionate about making life easier for people living with a neck stoma, by providing personalized care and innovative solutions. You will be instrumental in leading technical file development in projects run in a user-centric perspective, making sure we solve for true needs and bring real value to our customers. Utilizing agile methods, we iterate our solutions until we have found what can be confirmed as satisfactory for our customers.

 

While continuing our mission to improve the everyday life of individuals breathing through a neck stoma, we are looking for the next star to join the team and launch the next phase in their career.

 

You will be part of an R&D team and will report to the manager responsible for new product development in laryngectomy care. Our R&D facilities is located in Hörby, only 25 min north of Lund but we do apply a hybrid setup where part of the job can be carried out remotely.

 

Your responsibilities

At Atos Medical you will lead and make sure that our product portfolio is relevant and attractive from a customer standpoint. Collaboration with risk management, medical and scientific affairs, global marketing, quality and operations will be part of your everyday reality. In this role you will:


• Be an active player in a cross functional product development team where you will drive product requirements engineering, system engineering and design reviews
• Use your understanding of the customers needs to define user need, design inputs and as input to the usabililty engineering process and documentation
• Lead the creation of design and development documentation to support the regulatory files and to support clinical studies according to FDA, ISO and MDR
• Lead and manage post market surveillance activities for the category


• Continuously improve design controls and guide the team in how we best balance design quality and agility

 

About you

You will be part of an entrepreneurial, informal yet ambitious work environment in which international teams work together to continuously grow and develop the business.

You will have great opportunities to be challenged, to learn and develop your professional and personal competencies.

To be successful in the role as Design Control Specialist:

 


• Degree in engineering, pharmaceutics, life science or similar
• Extensive communication skills in English and Swedish 
• Good understanding of complex technical challenges with a  positive attitude and  used to work in a cross functional product development team
• Requirements engineering or system engineering
• Regulations, standards and guidelines within the medical device area e.g. MDR, ISO 13485, ISO 14971 and FDA 21 CFR 820.30
• Driving and documenting design control activities such as requirement engineering, design verification and facilitating design reviews
• Knowledge in statistical methods and risk management

 

Does this sound like the perfect challenge for you? Please send your application today, applications will be reviewed on an ongoing basis.

If any questions, feel free to reach out to hiring manager, Diana Tieger, via email: Diana.Tieger@atosmedical.com

 

About Us

Atos Medical develops and sells medical devices, driven by the desire to make life easier for people living with a neck stoma in over 90 countries.

 

Since our foundation in 1986, we have cemented ourselves as the leaders in neck stoma care, and today our business includes innovative products in laryngectomy and tracheostomy care to help people breathe, speak and live well.

 

We are a truly global organization with Swedish roots made up of about 1200 employees and 25 subsidiaries worldwide. Atos Medical is a part of Coloplast A/S.

 

For more information, please visit our career page www.atosmedical.com/about/life-at-atos-medical/