Senior Verification Engineer

Full SpectrumBoston, MA
$90,000 - $165,000

About The Position

Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps are becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of engineering driven innovation. If it excites you to develop new products and learn new technologies on a regular basis from a diverse set of customers, then this is the place for you. We have a passionate team of experienced professionals who have first-hand experience developing products. Our clients are dependent on us to develop their next innovative product to bring to market. Come help us build the future, come join Full Spectrum! A Verification Engineer is a technical position responsible for testing and verification of software as a medical device, medical device systems and software embedded medical devices. Verification Engineers are responsible for V&V planning, mapping of test types, associating design requirements into test groups, developing test method and test cases to verify requirements, creating protocols and execution/documentation of verification tests within schedule constraints, meeting quality standards and goals.

Requirements

  • 5-10 years experience as a verification engineer

Nice To Haves

  • Test case and protocol development for medical device applications.
  • Experience writing formal test reports that meet Good Documentation and Lab practices.
  • Experience writing test scripts with creating Automated Test cases a plus.
  • Experience with software or medical devices that have been reviewed or certified by test houses or notified bodies.
  • Use of LabVIEW or similar environment to aid in verification of systems.
  • Author automated Test Scripts a plus.
  • Writing test cases, protocols
  • Test case development for GUI and GUI workflows
  • Negative and positive testing for functional test cases
  • Test planning, protocol writing
  • Test report writing.
  • Requirements review an allocation
  • V&V planning experience
  • Test tools and test automation experience
  • Understanding of software Development lifecycle and Agile development
  • IEC62304
  • Performance testing medical device systems
  • Statistics experience, sample size determination

Responsibilities

  • Estimate, plan, develop, execute, and maintain manual test cases and test protocols for products under development.
  • Writing skills to develop documentation including testing plans, detailed test cases, and verification protocols.
  • Work with different Test Environments to execute the test cases.
  • Perform Software, Hardware, Application, GUI and/or Back-End testing.
  • Design and develop functional tests based on system specifications.
  • Work with project management to meet the testing milestones and deliver high quality solutions on time.
  • Ensure that FDA-regulated medical products are tested in adherence to the applicable standards, regulations (ISO 13485, IEC 62304) and best practices.
  • Manage relationships with clients
  • Contributing to the continuous improvement of verification engineering practices
  • Identify opportunities to drive further value in client engagements
  • Reviewing risk analysis and experience working on FMEA’s as it relates to test failures
  • Understanding of FDA design controls and Software V&V for medical devices
  • Understanding of standards impacting verification of medical devices such as IEC62304
  • Understanding of issue tracking, issue tracking process and management of issues list in a bug tracking tool

Benefits

  • bonus eligible
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