Sr Engineer (Software Test)

Fresenius Kabi USA•North Andover, MA

22h•$95,000 - $100,000•Hybrid

About The Position

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.

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.

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.