Senior Engineer (Software Test) responsible for designing, building, and maintaining software test processes for medical technology. Collaborates on Ivenix Infusion System ensuring compliance in a regulated environment.
Responsibilities
Define and execute test cases for new and existing Ivenix Infusion System products.
Follow pre-established testing procedures.
Accurately assess results for validity and conformance to specifications.
Develop and maintain detailed documentation for both internal and external customers.
Trace test activities and results to system and subsystem requirements, escalating findings through the defined workflows.
Operate within defined processes and procedures consistent with a regulated environment.
Work on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
Effectively operate as an individual contributor and a member of the large team.
Set up and maintain 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.
Participate 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.
Benefits
401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits including medical, prescription drug, dental and vision coverage
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