Senior Verification Engineer

Sr. Verification Engineer

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.

Role 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

• 5-10 years experience as a verification engineer

Preferred Experience:

• 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

The base salary for this position is $90,000 to $165,000 annually, and the role is bonus eligible.

The final salary offer is determined by factors such as experience, location, skills, education, and market conditions.