Software Quality Assurance Engineer


Position Summary

The Software Quality Assurance Engineer is responsible for the testing of software throughout the product lifecycle. You should have demonstrated experience in software quality assurance for medical devices. Ideal candidates will include those who have designed and implemented software testing frameworks, including unit testing, automated testing, and assurance of the complete SDLC. The SQA Engineer will take ownership of projects, develop and coordinate V&V plans, work from requirements to create test cases, and execute the tests per project schedule. This is a collaborative opportunity where the individual will work with software engineers, other engineering disciplines, and quality.

Primary Responsibilities

  • Design, implement, and execute software verification using best practices, including continuous software testing to support the Quality Assurance goal of making quality a competitive advantage
  • Provide and maintain domain expertise of relevant software technologies and products
  • Take ownership of projects and independently work through completion and final delivery, including developing, executing, and reporting of V&V plans and complex test protocols
  • Ensure compliance with internal and external software standards (e.g., adherence to IEC 62304)
  • Participate in software design controls activities of New Product Development (NPD) software as well as software used in the production process
  • Participate in development of system Integration and Verification Plans

Desired Skills and Experience

  • BS Degree in Computer Science or related engineering discipline
  • 5-8 years in the field of software with at least 3 years of experience testing medical software products from embedded software to GUI required
  • Experience with developing or testing in compliance with recognized standards (e.g., FDA 21 CFR 820.30, ISO 13485, IEC 62304) required
  • Experience with defect tracking and metrics required
  • Experience using automated testing tools for continuous integration required
  • Experience with development of embedded software and custom electronics preferred
  • Experience integrating software, electronic hardware, and mechanical subsystems preferred
  • Experience with requirements management software such as Helix ALM, Jama, or DOORS preferred
  • Experience with system and software modeling tools such as Enterprise Architect or Rational Rhapsody preferred
  • Programming skills using an object-oriented language, such as C++, preferred
  • Strong communication skills preferred
  • Ability to travel up to 10% required
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