Sr Principal Engineer (Software HIT Test)

Fresenius Kabi USANorth Andover, MA
2d$145,000 - $155,000Hybrid

About The Position

Highly experienced engineering position, under minimal or no direct supervision guides the testing and testing analysis for maintaining software used in medical devices and engineering projects related to medical technology. Applies standard test engineering practices to resolve problems of high complexity. May assist and mentor experienced engineers.

Requirements

  • Bachelor’s degree in Engineering is required, Information Technology or related field is preferred.
  • 8+ years of experience in software engineering, troubleshooting, and solving problems.
  • Experience in the software development life-cycle methodology and software product testing. Experience of medical device development processes and FDA regulations a plus.
  • Experience with C#, .NET Framework / .NET Core, SQL Server, Windows Services and Web Services is required.
  • Advanced experience with various types of testing such as Unit, Integration, System, Performance, Regression, and Exploratory is required.
  • Demonstrated experience writing, maintaining, and debugging C# unit and automated tests using standard .NET testing frameworks. Experience with additional languages such as Python or JavaScript is a plus.
  • Experience with HTTP, SOAP, and REST protocols and working knowledge of SQL Server for data validation, troubleshooting, and test verification
  • Experience in integrating automated tests into CI/CD pipelines is required.
  • Experience working with virtual and cloud environments is required. Experience with VMWare is desired.
  • Ability to diagnose and solve complex problems involving multiple technologies.
  • Knowledgeable in source control management and configuration. Experience with Git/Bitbucket desired.
  • Ability to work as a collaborative team member.
  • Advanced in problem solving, analytical, troubleshooting, and debugging skills.
  • Strong attention to details, natural inclination to be methodical.
  • Excellent in written and verbal communication skills

Nice To Haves

  • Experience of medical device development processes and FDA regulations a plus.
  • Experience with additional languages such as Python or JavaScript is a plus.
  • Experience with cloud services such as Azure, AWS, GCP is desired.
  • Experience with microservices and Kubernetes is desired.
  • Experience with VMWare is desired.
  • Experience with implementing UI and end-to-end automated tests, using tools such as Selenium, Playwright, or Cypress preferred.
  • Experience with Git/Bitbucket desired.

Responsibilities

  • Guides the conceptualization of new methodologies while identifying improvements for processes and best practices in software testing.
  • Generates innovative test solutions to complex problems using multiple disciplines and technical principles.
  • Measures test effectiveness, including defect trends and automation performance, and advises senior management on quality risks and recommended actions.
  • Analyzes, plans, designs, executes, and documents tests of highly complex software applications and/or processes within established medical product design controls.
  • Plans and performs unit testing (including C# unit tests), integration, system, and regression testing for new features, enhancements, and defect fixes across multiple software subsystems.
  • Designs and develops automated tests using reusable and scalable components to support repeatable testing and CI/CD pipelines.
  • Perform exploratory and ad-hoc testing to identify defects, edge cases, boundary conditions, and failure modes not covered by scripted or automated tests.
  • Works with senior leadership to improve software engineering process efficiency.
  • Works with internal and external staff to identify test coverage needs, high-risk areas, and negative scenarios, and to improve overall software testability, robustness, and other software engineering activities.
  • Investigates and documents software defects, working across services, interfaces, data layers (including SQL-based systems), and environments.
  • Mentors and guides junior staff, routinely provides technical input on architecture and design decisions to improve observability, testability and diagnosability, while remaining a hands-on individual contributor within the development team.
  • May supervise or direct Sr engineers and lower-level engineers on assigned projects.
  • Develops and maintains technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.
  • All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Benefits

  • comprehensive benefits and programs
  • 401(k) plan with company contributions
  • paid vacation, holiday and personal days
  • employee assistance program
  • health benefits to include medical, prescription drug, dental and vision coverage
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