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Fresenius Medical Care

Operates dialysis facilities and renal care

Verification 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 an engineering discipline is required; mechanical engineering is preferred.
  • At least 3 years of professional experience developing products in regulated industries is required.
  • At least 3 years of component-level hardware verification experience is required, particularly for components in the water inlet circuit, mixing system, and balancing circuit of active medical devices.
  • Experience handling various test and measurement equipment is required.
  • Experience in medical-device development or another regulated industry is required.
  • A solid understanding of product development processes and component-level quality methods is required.
  • A deeper understanding of the functions and verification of components in the water inlet circuit, mixing system, and balancing circuit of active medical devices is required.
  • Knowledge of relevant medical-device regulations and standards, including the ISO 13485 and IEC 60601 families and related development standards, is required.
  • A deeper understanding of component lifetime-testing concepts in verification is required.
  • Good knowledge of statistical analysis of test results using statistical software such as Minitab is required.
  • Professional working relationships and communication with colleagues and internal and external customers are required.
  • Strong communication skills are required for working across departments.
  • Willingness to travel occasionally is required.
  • Very good spoken and written German and English are required.

Responsibilities

  • Plan, conduct, and evaluate tests on mechanical and fluid-carrying components and their mechanical and functional interfaces, particularly components in the water inlet circuit, mixing system, and balancing circuit of active medical devices.
  • Further develop, build, and validate test setups for mechanical and fluid-carrying components, particularly existing test setups and methods for compliance testing of fluid-carrying components in the hydraulic section of active medical devices.
  • Independently conduct component and assembly tests in accordance with test methods, standards, and specifications, ensuring long-term reliability and compliance with internal standard processes.
  • Independently perform data analyses and evaluate test results.
  • Prepare test documentation in English for development projects and product-change processes in accordance with applicable quality-management requirements.
  • File and release verification documentation in PDM databases and ALM systems.
  • Ensure quality and on-time delivery for assigned tasks and all associated work packages.
  • Participate as a subject-matter expert in design reviews, requirements analyses, and change assessments with stakeholders.
  • Contribute to requirements management and product architecture for active medical devices.
  • Work with defined documentation structures, tools, and processes for verification activities.

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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