AdressWe now have an open position as Senior Team Manager for the Design Control, Risk Management and Usability team in our R&D department in Hörby.
About the role
To pursue our ambitious growth strategy, we are looking for a Team Manager for Design Control, Risk Management and Usability. The team is part of the R&D Product Development team and consists of 4 dedicated specialists in Design Control, Risk Management and Usability Engineering. The team is recently established so you will be part of forming how we work with Design Control, Risk Management and Usability in the future. Currently, the specialists are core member of the product development project and sets the strategy for bringing the products to the market with a pragmatic and compliant design and development process and documentation.
Your key responsibilities will be to:
- Support and lead the specialists in the team in the innovation projects.
- Ensure the professional and personal development of team members, caring for their motivation and engagement.
- Help deliver product development projects on time by setting the right direction for Design Control, Risk Management and Usability in the innovation projects.
- Support collaboration with key stakeholders such as Project Managers, Marketing, Engineers, RA and Operations.
- Own the Design Control, Risk Management and Usability QMS processes, ensure compliant documentation and participate in audits.
- Support sustaining engineering projects and MDR updates with Risk Management resources
The role is based on our site in Hörby however, we do apply a hybrid solution meaning you will have flexibility to work from home or our Malmö office, when the job allows you to. Most employees work from home 1-2 days a week.
About you
You will be part of an entrepreneurial, informal, and ambitious environment in which international teams work together to continuously grow and develop the business.
This is our wish list of requirements for the profile:
- You have an academic background at Masters level within engineering, life, natural and/or applied sciences.
- You have solid experience with medical device product development and/or usability engineering and have a good understanding of medical device regulations, guidelines and standards such as FDA Quality System Regulation, ISO 13485, ISO 14971, Medical Device Regulation (MDR) and IEC 62366.
- You have a pragmatic mindset and is able to set plans for documentation and activities based on risk- and value-driven decision making in a highly-regulated environment.
- You are enthusiastic and visionary and strive to improve.
- You know how to navigate a diverse stakeholder landscape, and how to coordinate and facilitate tasks that span from several aspects within the medical device development value chain.
- It is an advantage to have leadership experience but not a prerequisite.
Interested?
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, Marie Hasemann, via email: marie.hasemann@atosmedical.com
Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.
We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business.
Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.
Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S
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