Job Summary

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

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

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).

Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related technical discipline with 2+ years related experience.

• Experience working in an Agile environment and using work management, source control, and test management tools. Jira, Confluence, and Bitbucket experience is preferred.

• Experience creating test plans, detailed test cases, traceability, objective evidence, defect reports, and test summary reports.

• Hands-on experience testing enterprise Windows software and embedded-device solutions, including troubleshooting issues across hardware, application, database, and network layers.

• Experience with TCP/IP networking, DNS, TLS/SSL certificates, network troubleshooting tools, web services, and REST APIs.

• Experience with Microsoft SQL Server and SQL-based data verification is preferred.

• Experience verifying software solutions in regulated industries, including medical devices, healthcare technology, or other quality-controlled environments.

• Strong analytical, troubleshooting, and problem-solving skills, including the ability to reduce complex system failures into actionable findings.

• Excellent written and verbal communication skills, including the ability to clearly state the issue, impact, evidence, owner, dependency, and next action.

• Experience working with distributed or offshore development and test teams.

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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness 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.