Lead Systems Engineer for Medical Devices

vor 3 Wochen

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

Job Title: Senior Systems Engineer (Design Lead)

Company: Fresenius Medical Care

As a Senior Systems Engineer (Design Lead), your primary responsibility will be to develop intricate systems, sub-systems, and components, while also performing concept and feasibility analyses with a strong emphasis on the functional safety of medical products. You will be tasked with the creation and ongoing maintenance of product requirements. Operating with a high degree of autonomy, you will be self-driven to spearhead the execution of technical objectives.

Within the PD Systems Engineering division, we focus on the development of Peritoneal Dialysis machines designed for the treatment of chronic kidney failure.

Your Responsibilities:

  • Engage collaboratively with various departments, including Mechanics, Electronics, and Software, to design products for PD machines and oversee technical activities at the product level.
  • Establish the technical product structure and its components.
  • Develop and maintain architecture documentation, excluding software components.
  • Oversee the Product Requirement Document (PRD) by analyzing customer needs, structuring product requirements, and assisting in deriving component specifications.
  • Serve as the primary contact for design inquiries, guiding the design concept and execution for a complete PD device in accordance with relevant product standards.
  • Assess technical solutions, robustness, and maturity concepts, while supporting technical risk mitigation strategies.
  • Participate in model creation at the product level (PTC-Modeler) in collaboration with the Therapy System Architect.
  • Play a pivotal role in adopting a model-based engineering methodology.
  • Work independently with external development partners and service providers.
  • Conduct Design-Failure Mode and Effects Analyses (FMEAs).

Your Qualifications:

  • A degree in Electrical Engineering, Physics, Medical Technology, Computer Science, or a related field.
  • Extensive experience in the development of complex technical devices, ideally within the medical technology sector, with a strong foundation in requirement management, design, and verification.
  • Proven experience in leading interdisciplinary technical teams.
  • Expertise in developing and maintaining complex product architectures through a model-based approach.
  • Significant experience in stakeholder and requirement management.
  • Knowledge of functional safety, particularly in the context of medical products, is a plus.
  • Strong IT proficiency, including MS Office, Polarion, and Windchill.
  • Willingness to travel occasionally for national and international engagements.
  • Fluency in both German and English.

About Fresenius Medical Care:

Fresenius Medical Care provides employees with the opportunity to make a significant impact by developing treatments that enhance lives. The company fosters continuous development and promotes a supportive team environment aimed at achieving optimal healthcare outcomes. By embracing diversity, Fresenius Medical Care values a range of backgrounds and experiences, creating an inclusive workplace where every employee is appreciated. As a leading provider of hemodialysis machines, employees enjoy stability and security while contributing to the improvement of patient lives. Additional benefits include professional development programs, region-specific local benefits, and initiatives aimed at promoting work-life balance, such as flexible hours and remote work options.

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