Profile
Xyall is looking for a system architect with a technical background who can successfully lead and manage equipment design projects from customer requirements early in the project towards validated medical equipment delivered into the field. The system architect will be involved with stakeholders from all departments both internally and externally. The initial focus will be on finalizing the technical documentation set and verification of the technical design to enable FDA approval for clinical use. In a next step the design will be optimized to meet extended customer requirements and reduced costs.
Key Areas of Responsibility
- Assess customer requirements and create system and design specification
- Define medical equipment design architecture on module and part level
- Follow a systematic project management approach with stage gate reviews
- Define testing and validation guidelines
- Support and review work packages which are required to successfully meet product creation processes and milestones
- Support testing, release and installation of equipment to experience equipment optimizing opportunities first hand
- Willingness to travel 5-10%
Role Overview
Together with customers, the Xyall team and suppliers drive successful equipment development and upgrades in the field.
Placement in the Organization
The system architect is a full time position and member of the Management Team, reporting to the COO of Xyall.
Requirements
- Technical MSc
- 10 years of relevant experience in a technical environment
- Proven experience in project management
- Good communication and social skills
- At ease with customer interaction
- Experience in healthcare/medical devices (ISO13485, FDA) is an advantage
- Experience in web-based applications is an advantage