Sr Engineer (Software Test)

Fresenius; Andover (MA); On-site; USD 98,000 - 105,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Health benefits

Job summary

Fresenius Kabi is seeking an engineering professional to design, build, and maintain testing processes for software products used in medical devices. The role requires applying standard engineering practices to verify software products and participate in validation efforts.

The position offers a competitive salary in a regulated environment with comprehensive benefits and career growth opportunities. Applicants must be authorized to work in the United States; sponsorship is not offered.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field preferred.
• Minimum 2 years of experience in a regulated industry (medical device, ISO/FDA environments) preferred.
• Experience in medical device software development and testing preferred.
• Experience in a regulated industry is preferred.
• Experience in Agile environments preferred.
• Experience with test case execution and reporting required.
• Experience designing and developing manual test cases for complex systems and components required.
• Excellent written and verbal communication skills.
• Strong problem-solving and analytical skills.
• Proven ability to work collaboratively in cross-functional teams.
• Experience working in virtual environments (VMware or Hyper-V) preferred.
• Experience testing devices with embedded Linux systems and platforms (IIS, ASP.NET, Web/Windows Services, SQL) preferred.
• Experience with Windows Server administration and interpreting error logs preferred.
• Proficiency with test-automation tools such as Selenium WebDriver, Squish, and Python preferred.

Responsibilities

• Defines and executes test cases for Ivenix Infusion System products following pre-established procedures.
• Develops and maintains detailed documentation for internal and external customers.
• Traces test activities and results to system requirements and escalates findings as needed.
• Operates within defined processes in a regulated environment and resolves routine issues.
• Works as an individual contributor and as part of a large team, managing test articles and fixtures.
• Participates in technical reviews and prepares documentation for assigned projects.

Skills

Test case execution

Analytical skills

Verbal and written communication

Cross-functional collaboration

Agile experience

Education

Bachelor’s degree in Engineering or Computer Science

Tools

Selenium WebDriver

Squish

Python

VMware

Hyper-V

IIS/Web services/ASP.NET

SQL

Windows Server administration

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.

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 elevate 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 andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.