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Fresenius Kabi USA is seeking a Senior Engineer to plan, execute, and document interoperability testing across medical devices, lab instruments, third-party systems, and data management software. You will verify end-to-end connectivity, data exchange, and interfaces while collaborating with cybersecurity and verification teams.
The role is hybrid (onsite 3 days per week) and offers a salary range of $88,000–$92,000 based on experience, education, and abilities, with a comprehensive benefits
The Sr Engineer works under moderate supervision to plan, coordinate, execute, and document interoperability testing between medical devices, laboratory instruments, third-party systems, and data management software. The role verifies end-to-end device connectivity, data exchange, configuration, control interfaces, error handling, and recovery behavior across representative hardware, software, database, and network configurations. The engineer works with systems, software, verification, and cybersecurity teams to identify integration risks early and provide objective evidence supporting product quality, validation, compliance, performance, and release readiness.
Hybrid Role: Onsite 3 days per week
Salary Range: $88,000-$92,000 based on experience
Develops and maintains integration test strategies, plans, protocols, test cases, traceability, test data, and test reports for embedded devices integrated with the DXT data management software system.
Analyzes product, system, interface, cybersecurity, and regulatory requirements to define positive, negative, boundary, fault-injection, interoperability, and recovery test coverage.
Sets up and maintains representative integration test environments, including DXT software running on Windows based servers utilizing IIS, Microsoft SQL Server, network infrastructure, embedded devices, simulators, and supporting tools.
Verifies interfaces and protocols used by software and connected devices, including network communications, web services, and REST APIs, as applicable to the assigned product.
Coordinates integration test dependencies across local and offshore teams, including device availability, DXT build alignment, environment readiness, test data, ownership, and timing.
Supports regression testing, formal verification and validation activities, release execution, post-release investigation, and service-level technical troubleshooting for integration-related issues.
Develops and maintains detailed technical documentation for internal and external stakeholders in accordance with defined design control, quality, and document management processes.
Operates within defined processes and procedures and determines appropriate actions consistent with a regulated medical device software environment.
This job position within the Business Unit - Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).
The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.