FRESENIUS MEDICAL CARE
- Support and manage, accomplish and document the Usability engineering process in conformance with the normative standards (e.g. ISO/IEC 62366, ISO 14971, ANSI/AAMI HE75).
- Coordination of all measures for compliance required by e.g. ISO/IEC 62366 requirements for usability-oriented development process and sustaining engineering (analysis, design, evaluation)
- Manage, monitor, assess and document the formative and summative evaluations, using appropriate methods and document accordingly
- Organize recruitment of test participants, organize test environment and tools
- Support and consult the Usability-Engineering & Requirement process in cooperation with stake holders
- Customer and user needs analysis, context analysis, workflow analysis.
- Support and consult the process of generating product documentation & terminology.
- Support and consult the generation of product specific documentation IFU / SM / Service Tools.
- Definition of product / system specific training content and training material.
- Support the market preparation activities to enter the markets
- Competitor Analysis in terms of Usability Engineering and user context;
- Post market questionnaires.
- Organization, coordination, support and maintenance of the usability lab with all the necessary accessories, video and audio technology for conducting usability assessments
Required Skills and Abilities
- BA/BS in Biomedical Engineering and /or Usability/Human Factors Engineering and/or Industrial Design
- Good knowledge in Workflow and Process analysis
- Fluent written and spoken English
- Solid Knowledge in MS Office, Basic Knowledge in Electronic Data Management
- Willingness to travel (10-15%)
- Knowledge in usability engineering management
- Experience in the medical device industry
- Experience of international regulatory and normative standards of medical device
- Good knowledge of Project Management methodologies tools and best practices
- Strong commitment and flexible organization of working time and environment
- Demonstrates initiative; results oriented; strong sense of urgency
- Strong analytical, planning, organization and time management skills
- Profound analytical skills and exceptional network thinking capability
- Intercultural experience and skills
Closed 2 months ago
- Job type:Graduate Jobs
- Closing Date:15th Mar 2020, 6:00 pm