Sr Engineer (Software Test)

Posted 12 Hours Ago
3 Locations
In-Office or Remote
98K-105K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Defines and executes manual and automated software test cases for medical device products, validates results against specifications and requirements, documents test activities, maintains test fixtures, investigates issues, and escalates findings in a regulated environment. Collaborates on technical reviews, prepares project documentation, and supports testing of embedded Linux systems, Windows services, SQL platforms, and virtual environments.
Summary Generated by Built In
Job SummaryAn 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.

Skills Required

  • Bachelor's degree in Engineering, Computer Science, or a related field
  • At least 2 years of experience in a regulated industry
  • Experience in medical device software development and testing
  • Experience working on a medical device or in another regulated industry
  • Experience working in an Agile environment
  • Experience with test case execution and reporting
  • Experience designing and developing manual test cases for complex systems and components
  • Excellent written and verbal communication skills
  • Thorough understanding of software testing principles and best practices
  • Strong problem-solving and analytical skills
  • Ability to work collaboratively as part of a cross-functional team
  • Experience working in virtual environments
  • Experience with VMware or Hyper-V
  • Experience testing devices with embedded Linux systems and platforms using IIS, ASP.NET, Web Services, Windows Services, and SQL
  • Experience with Windows Server administration, setup, deployment, and configuration, including interpreting error logs
  • Proficiency with Selenium WebDriver, Squish, and Python
  • Effective ability to speak, read, write, and understand English
  • Authorization to work for any employer in the United States without visa sponsorship
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The Company
HQ: Bad Homburg v.d.Höhe
21,388 Employees

What We Do

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint

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