Senior Medical Device Software Test Engineer

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

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.