Senior Medical Device Verification Engineer

Socket.dev; Boston (MA); On-site; USD 90,000 - 165,000; Full time

Job summary

Full Spectrum is seeking a Sr. Verification Engineer to lead testing for medical device software and hardware. This role focuses on V&V planning, creating test methods, protocols, and execution within quality standards.

Responsibilities include developing manual test cases, writing verification documentation, coordinating with environments, and ensuring adherence to ISO 13485, IEC 62304, and FDA design controls while collaborating with clients to deliver robust solutions.

Qualifications

• 5–10 years of experience as a verification engineer.
• Experience with FDA-regulated medical devices and design controls.
• Knowledge of ISO 13485 and IEC 62304 compliance.
• Experience with test planning and protocol development.
• Ability to review risk analyses and FMEA related to testing.

Responsibilities

• Estimate, plan, develop, execute, and maintain manual test cases and test protocols.
• Write documentation including testing plans and verification protocols.
• Work with different test environments to execute test cases.
• Perform software, hardware, GUI and back-end testing.
• Design functional tests based on system specifications.
• Coordinate with project management to meet milestones.

Skills

Test case development

V&V planning

Test automation

Software testing

Agile development

IEC62304

Tools

LabVIEW

Bug tracking

Job description

Full Spectrum is seeking a Sr. Verification Engineer to lead testing for medical device software and hardware. This role focuses on V&V planning, creating test methods, protocols, and execution within quality standards.

Responsibilities include developing manual test cases, writing verification documentation, coordinating with environments, and ensuring adherence to ISO 13485, IEC 62304, and FDA design controls while collaborating with clients to deliver robust solutions.