Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone to grow personally and professionally. Sound interesting?
Then come and join our global team as
Usability & Risk Management Scientist (M/F/D)
Your main tasks and responsibilities:
- Implement usability engineering standard IEC 62366-1, “Application of usability engineering to medical devices”.
- Define usability plans, plan and organize usability related activities in close collaboration with project team members, e.g. R&D, Clinical, Marketing, etc.
- Perform usability testing during the product development phases e.g. formative and summative testing.
- Identify and implement usability improvements by means of analyzing customer feedback, post market data and competitor`s product analysis.
- Support and execute risk management documentation according to ISO 14971 following the internal risk management process for the products during their entire life cycle
- Execute risk assessment for new development projects as well as for design changes and post market surveillance in close collaboration with project team members, e.g. R&D, Clinical, Marketing
- Interact with internal cross-functional teams as well as with external collaborators
- Document all stages of development in compliance with regulatory requirements
- Travel activity if required.
Please click here for more information about our Business Activities.
Your qualifications and experience :
- Master or PhD. in scientific field such as Molecular Biology, Microbiology or a similar field
- Experience with medical device regulations (CE certification in EU and FDA clearance in US) and working with a quality management system (ISO 13485); and are experienced in Design Control Procedures
- Prior experience in the compilation and maintenance of Usability Files and Risk Management Files is an asset.
Your attributes and skills:
- Professional working knowledge of common software packages (Word, PowerPoint, Excel)
- Excellent written and spoken English language skills
- Capacity for working independently as well as in cross-functional teams
- Excellent interpersonal and organizational skills
- Will to work in an international team within a highly collaborative environment
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site !
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Mid-level Professional
Job Type: Full-time