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Software Quality Assurance Test Engineer - Med Device

Job Description

Position Title: Software Quality Assurance Test Engineer

Company Background

Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to percutaneous coronary and peripheral interventions. Corindus is advancing the field of interventional medicine with robotics through improvements to procedural control, precision and workflow.

Position Summary:

The Software Quality Assurance Test Engineer is responsible for the execution of software testing for several next generations products, throughout the given product’s lifecycle. You should have demonstrated experience in software quality testing for medical devices. Ideal candidates will include those who have executed a variety of software development testing, including unit testing, automated testing, and assurance of the complete SDLC. The SQA Test Engineer will take ownership of software test method and test protocol execution, and will document results in reports as necessitated by a project schedule.  

This is a collaborative opportunity where the individual will work with software engineers, other engineering disciplines, and quality engineers.

Primary Responsibilities:  

  • Execute software verification and validation 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 project testing and independently work through completion and final delivery, including developing, executing, and reporting of V&V test protocols, and documenting of traceability from requirements to completed tests.
  • 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.
  • Performs other duties assigned by the team, as necessary.

Qualifications:

  • BS Degree in Computer Science or related engineering discipline.
  • 3 years in the field of software with at least 1-2 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 in the whole software development lifecycle from requirements to test reporting.
  • Experience with the software issue resolution process.
  • Experience with defect tracking and metrics required.
  • Experience using automated testing tools for continuous integration, such as Azure DevOps and Jenkins, preferred.
  • 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.
  • Experience with Linux/Unix scripting, preferred.
  • Programming skills using an object-oriented language, such as C++/Python, preferred.
  • Strong communication skills preferred.
  • Ability to travel up to 10% required.


Organization: Siemens Healthineers

Company: Corindus, Inc.

Experience Level: Mid-level Professional

Job Type: Full-time



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Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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