Sr Engineer (Software Systems)
Fresenius Kabi USA
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.
Job description
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.
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.
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.
- Must be able to effectively speak, read, write, and understand English.
Requirements
- Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related technical discipline
- 2+ years related experience
- Experience working in an Agile environment and using work management, source control, and test management tools
- 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
- 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 verifying software solutions in regulated industries
- Strong analytical, troubleshooting, and problem-solving skills
- Excellent written and verbal communication skills
- Experience working with distributed or offshore development and test teams
- Must be able to effectively speak, read, write, and understand English
- Jira, Confluence, and Bitbucket experience preferred
- Microsoft SQL Server and SQL-based data verification preferred
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Personal Days
- Employee Assistance Program
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Wellness Program
Company overview
Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.