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Fresenius Medical Care

Operates dialysis facilities and renal care

Design Quality Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeSchweinfurt, GermanyNo salary listedHybrid

About the Job

Requirements

  • A completed technical degree in a scientific or engineering discipline is required.
  • At least five years of product development experience in regulated industries, including at least three years in medical technology, is required.
  • Experience in systems engineering and/or electronics development is required.
  • Experience developing medical devices or working in another regulated industry is required.
  • A solid understanding of product development processes and system-level quality methods is required.
  • Good professional relationships and communication with colleagues and internal and external customers are required.
  • Strong communication skills are required due to interfaces with other departments.
  • Willingness to travel occasionally is required.
  • Very good written and spoken German and English are required.

Responsibilities

  • Advise and support system-level quality assurance, including system integration testing, interface testing, release readiness, and defect handling.
  • Collaborate with interdisciplinary engineering teams from early development phases to provide quality assurance input and support.
  • Evaluate modern system and electronics quality methods, track progress, and introduce improvement plans.
  • Define and monitor quality metrics and communicate risks and quality status to stakeholders.
  • Create project-specific quality strategies and operationalize them through tailored measures.
  • Support the management of defects, deviations, anomalies, and nonconformities.
  • Identify opportunities to improve system quality processes, methods, and templates using lessons learned and feedback.
  • Plan, coordinate, support, review, and facilitate design FMEAs, particularly for electronic and mechatronic subsystems, to identify and address potential design weaknesses early in development.
  • Advise development teams on FMEA methodologies, including dFMEA and System FMEA, and on tool use, templates, and process optimization.
  • Improve existing product life-cycle processes and support compliance with current regulatory requirements for medical technology systems.

Desired Qualifications

  • Knowledge of relevant medical-device regulations and standards, such as ISO 13485, ISO 14971, the IEC 60601 family, and related development standards, is advantageous.

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size
11-50
Company stage
Late Stage VC
Total funding
$40.2M
Headquarters
Waltham, MA
Founded
1996

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