Senior Verification Engineer

Full Spectrum; Andover (MA); On-site; USD 90,000 - 165,000; Full time

Job summary

Full Spectrum is seeking a Verification Engineer to test and verify software and hardware for medical device products. You will plan, develop, execute, and document verification activities, ensuring compliance with FDA design controls and ISO 13485/IEC 62304.

The role focuses on V&V planning, test protocol development, and cross-functional collaboration to deliver high-quality solutions on schedule. 90k–165k salary with bonus eligibility.

Qualifications

• 5–10 years of verification engineering experience.
• Experience with FDA-regulated medical products and related standards (ISO 13485, IEC 62304).
• Proficiency in creating verification protocols and test plans.
• Experience with GUI and software/hardware testing.
• FMEA review experience and involvement in risk analysis.
• Ability to write test scripts and automated tests.

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

Skills

Test planning

Test case development

LabVIEW

Automated testing

V&V

Agile

Documentation

Software testing

Requirements review

Test tools

Tools

LabVIEW

Bug tracking tools

Test automation frameworks

Job description

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.

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.
• Knowledge, Skills and Abilities:
• Test case development for GUI and GUI workflows
• Negative and positive testing for functional test cases
• Test report writing.
• Requirements review an allocation
• Test tools and test automation experience
• Understanding of software Development lifecycle and Agile development
• Performance testing medical device systems

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. **