Senior Verification Engineer - Medical Devices

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

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.