Sr Engineer (Software Test)
Fresenius Kabi USA
Summary
An engineering position, under moderate supervision, participates in designing, building, and maintaining processes to test and verify software products used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve simple problems, and contributes to the validation and verification of software products.
Job description
Job Summary
An engineering position, under moderate supervision, participates in designing, building, and maintaining processes to test and verify software products used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve simple problems, and contributes to the validation and verification of software products.
Responsibilities
- Defines and executes test cases for new and existing Ivenix Infusion System products. Following pre-established testing procedures. Ability to apply technical theories and principles. Accurately assess results for validity and conformance to specifications.
- Develops and maintains detailed documentation for both internal and external customers. Traces test activities and results to system and subsystem requirements, escalating findings through the defined workflows.
- Operates within defined processes and procedures consistent with a regulated environment. Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
- Effectively operates as an individual contributor and a member of the large team. Sets up and maintains test articles and test fixtures. Apply sound judgment to resolve routine and non-routine issues, follow established guidelines, and escalate when situations fall outside defined parameters.
- Participates in technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or related field is preferred.
- Minimum 2 years of experience in a regulated industry (e.g., medical device, pharmaceutical, or other ISO/FDA‑governed environments) is preferred.
- Experience in medical device software development and testing is preferred.
- Experience working on a medical device or other regulated industry is preferred.
- Experience working in an Agile environment is preferred.
- Experience with test case execution and reporting is required.
- Experience in designing and developing manual test cases for complex systems and components is required.
- Excellent written and verbal communication skills.
- Thorough understanding of software test principles and best practices needed to produce high-quality software.
- Strong problem-solving and analytical skills.
- Proven ability to work collaboratively as part of a cross-functional team.
- Experience working in virtual environments. Experience with VMWare or Hyper-V is preferred.
- Experience testing devices with embedded Linux systems and/or platforms using IIS, ASP.NET, Web/Windows Services, and SQL is preferred.
- Experience with Windows Server administration, setup, deployment, and configuration, and the ability to interpret error logs are preferred.
- Proficiency with test‑automation tools such as Selenium WebDriver, Squish, and Python is preferred.
- 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.
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Holiday days
- Personal days
- Employee assistance program
- Medical coverage
- Prescription drug coverage
- Dental coverage
- Vision coverage
- 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.