Senior Software Test Engineer - Medical Devices

Fresenius Kabi USA; Massachusetts; 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 (P

Job summary

Fresenius Kabi USA is seeking an engineer to design, build, and maintain test processes for medical-device software. You will execute test cases, validate results, and document activities across Infusion System products in a regulated setting.

Responsibilities include developing test strategies, tracing activities to requirements, and collaborating with cross-functional teams. Strong communication and problem-solving are essential; Agile experience is a plus.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field is preferred.
• Minimum 2 years of experience in a regulated industry (medical device, pharmaceutical, or ISO/FDA environments) is preferred.
• Experience in medical device software development and testing is preferred.
• Experience working in 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; VMware/Hyper‑V preferred.
• Experience testing devices with embedded Linux systems and/or platforms using IIS, ASP.NET, Web/Windows Services, and SQL preferred.
• Proficiency with test-automation tools such as Selenium WebDriver, Squish, and Python preferred.

Responsibilities

• Defines and executes test cases for new and existing Infusion System products following pre-established testing procedures.
• Develops and maintains documentation for internal and external customers; traces test activities to requirements.
• Operates within defined processes in a regulated environment; analyzes problems of simple to moderate scope.
• Acts as an individual contributor and team member; sets up and maintains test articles and fixtures; escalates when needed.
• Participates in technical reviews and organizes data and documentation for projects.

Skills

Problem-solving

Analytical skills

Written and verbal communication

Team collaboration

Education

Bachelor’s degree in Engineering/CS or related field

Tools

Selenium WebDriver

Squish

Python

VMware/Hyper‑V

Windows Server administration

SQL

Job description

Fresenius Kabi USA is seeking an engineer to design, build, and maintain test processes for medical-device software. You will execute test cases, validate results, and document activities across Infusion System products in a regulated setting.

Responsibilities include developing test strategies, tracing activities to requirements, and collaborating with cross-functional teams. Strong communication and problem-solving are essential; Agile experience is a plus.