Senior Verification Engineer bei Fullspectrumsoftware

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. S/he is 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.

· 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, 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 relate to test failures

· Understanding of FDA design controls and Software V&V for medical devices

· Understanding of standards impacting verification of medical devices sucha s IEC62304

· Understanding of issue tracking, issue tracking process and management of issues list in a bug tracking tool

· 5-10 years experience as a verification engineer

·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.

· Knowledge, Skills and Abilities:

· 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