The job holder (m/f/d) is responsible for the implementation of an efficient process for the collection and harmonisation of requirements for medical devices (hardware and/or software systems).
The expertise will ensure that the requirements of the product are fully and consistently agreed with all stakeholders and captured in a realisable, testable and understandable form.
- Implementation of an efficient process for eliciting requirements
- Organisation and moderation of workshops and reviews with all relevant stakeholders (e.g. product management, development, usability engineering, product compliance/risk management)
- Ensuring high quality and consistent formulation of the recorded requirements, e.g. by developing guidelines and work instructions in this area, by advising and supporting technical experts in analysing and formulating requirements
- Collaboration in the development and review of the General Product Requirements (GPR)
- Development, coordination and documentation of system requirements based on the GPRs
- Review of module requirements with regard to defined quality criteria
- Collaboration in the maintenance and validation of the requirement management system
