Senior Engineer for Medical Device Development

Vor 6 Tagen

Bad Homburg vor der Höhe, Hessen, Deutschland Fresenius Medical Care Vollzeit
About the Role

We are seeking a highly skilled Senior Systems Engineer to join our team as a Design Lead for Peritoneal Dialysis Systems. As a key member of our engineering team, you will be responsible for the development of systems, sub-systems, and components, as well as the execution of concept and feasibility analyses with a focus on functional safety.

Key Responsibilities
  • Develop product designs for PD machines in collaboration with various departments (mechanics, electronics, procedures/software) - lead technical activities at the product level
  • Define the technical product structure and product components
  • Develop and maintain architecture documentation (excluding software)
  • Product Requirement Document (PRD) responsibility - analyze customer requirements and develop and structure product requirements, support the derivation of component requirements
  • Main point of contact for design questions (concept creation and implementation) as Design Lead for a complete PD device, taking into account the applicable norms for the respective product
  • Evaluate technical solutions, robustness, and maturity concepts, support risk-minimizing measures (at the technical level)
  • Create models at the product level (PTC modeler) together with the therapy system architect
  • Significant participation in the introduction and rollout of a model-based engineering approach
  • Closely collaborate with external development partners and service providers
  • Conduct design FMEAs
Requirements
  • Completed technical studies (diploma, bachelor, master) in the field of electrical engineering, physics, physical engineering, medical technology, computer science, or a similar field
  • Several years of experience in the development of complex technical devices, preferably in medical technology with knowledge in the areas of requirement management, design, and verification
  • Relevant experience in leading technical teams
  • Expertise in creating and maintaining complex product architectures within a model-based approach
  • Comprehensive experience in stakeholder and requirement management
  • Knowledge in the field of functional safety, preferably of medical products, is advantageous
  • Good IT knowledge (MS Office, Polarion, and Windchill)
  • Willingness to travel occasionally in the national and international area
  • Very good German and English skills in writing and speaking

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