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.

Salary Range: $98,000-$105,000 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

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.

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.